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发帖数: 25265 | 1 Overview of FDA Modernization Act of 1997, Medical Device Provisions
CDRH FDA Modernization Act of 1997 Page1
Foreword
Preface
Introduction
Investigational Device Exemptions
Premarket Approval
Premarket Notification [510(k)]
Device Classification
Device Labeling
Device Tracking
Postmarketing Surveillance
Global Harmonization
Medical Device Reporting and Recall Reports
Establishment Registration
Device Standards
Other Sections Related to Medical Devices
Foreword
The Center for Devices and Radiological Health (CDRH) develops and
implements national programs to protect the public health in the fields of
medical devices and radiological health. These programs are intended to
assure the safety, effectiveness, and proper labeling of medical devices; to
promote quality in mammographic services; and to control unnecessary human
exposure to potentially hazardous radiation, and to ensure the safe,
efficacious use of such radiation.
The basic framework governing the regulation of medical devices is
established in the Medical Device Amendments to the Federal Food, Drug, and
Cosmetic (FFD&C) Act. The Medical Device Amendments were enacted on May 28,
1976. The FFD&C Act was again amended with respect to the regulation of
medical devices by the Safe Medical Devices Act of 1990 and the Medical
Device Amendments of 1992. New provisions governing the export of FDA
regulated products, including medical devices, were established in the FDA
Export Reform and Enhancement Act of 1996.
The FFD&C Act was most recently amended by the Food and Drug Administration
Modernization Act of 1997 (the Modernization Act). Signed into law on
November 21, 1997, the Modernization Act contained provisions related to all
products under FDA’s jurisdiction. This document summarizes each device-
related section of the Modernization Act in "plain English." It is not
intended to be interpretive or to set forth Agency policy for implementation.
We welcome your comments and requests for further information.
D. Bruce Burlington, M.D.
Director
Center for Devices and Radiological Health
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Preface
The Medical Device Amendments of 1976 mandated the establishment of "an
identifiable office to provide technical and other nonfinancial assistance
to small manufacturers of medical devices to assist them in complying with
the requirements of the FFD&C Act." The Division of Small Manufacturers,
International and Consumer Assistance (DSMICA) in the Office of
Communication, Education, and Radiation Programs was established to meet
this requirement. DSMICA develops educational materials and sponsors
workshops and conferences to provide firms with firsthand working knowledge
of medical device requirements and compliance policies.
This booklet covers the medical device provisions of the Modernization Act,
which amends the FFD&C Act.
For further information, contact the appropriate office within CDRH or call
DSMICA at 1-800-638-2041 or FAX 301-847-8149 , or Email us at d****[email protected]
.gov.
Additional copies are available from the Internet. You may also send an e-
mail request to d****[email protected] to receive an electronic copy of the
guidance or send a fax request to 301-827-8149 to receive a hard copy.
Please use the document number (1174) to identify the guidance you are
requesting.
Comments on this booklet, related workshops, and other DSMICA activities are
always welcome.
John Stigi
Director
Division of Small Manufacturers, International and Consumer Assistance
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Introduction
Congress amended the FFD&C Act in an effort to streamline the process of
bringing safe and effective drugs, medical devices, and other therapies to
the U.S. market.
With respect to medical devices, the FDA is directed to focus its resources
on the regulation of those devices that pose the greatest risk to the public
and those that offer the most significant benefits. The FDA must base its
decisions on clearly defined criteria and provide for appropriate
interaction with the regulated industry. The new legislation assumes that
enhanced collaboration between the FDA and regulated industry will
accelerate the introduction of safe and effective devices to the U.S.
The Modernization Act was signed into law by President Clinton on November
21, 1997. Most provisions went into effect on February 19, 1998 (90 days
from enactment of the Modernization Act), while some have different
effective dates or require implementing regulations.
This document presents a summary of each device related section of the
Modernization Act, combined under relevant headings, i.e. IDE’s, PMA’s,
510(k)’s. It includes a brief description of the new provisions, including
effective dates, and identifies applicable Federal Register (FR) documents.
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Sections Related to: Investigational Device Exemptions
Section 201 - Changes to Protocols and Devices
Section 201 - Early Collaboration of Data Requirements for Clinical Studies
Section 205 - Meeting on Evidence of Effectiveness for PMA’s
Section 203 - Expanded Humanitarian Device Exemption (HDE)
Section 402 - Expanded Access to Investigational Devices
Section 214 - Practice of Medicine
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Section 201 - Changes to Protocols and Devices
Clinical Protocol
Allows changes to be made to the clinical protocol, without additional FDA
approval, that do not affect:
1) validity of the data resulting from the study;
2) the risk to benefit ratio relied upon to approve the protocol;
3) the scientific soundness of the study, or
4) the rights, safety or welfare of the human subjects.
Device Manufacture and Design
Allows developmental changes to be made to the device in response to
information gathered in the trial (including manufacturing changes), without
additional FDA approval, provided they do not significantly affect the
design or basic principles of operation of the device.
Sponsor Requirements
The sponsor or applicant is responsible for determining that the change in
the protocol or the modification of the device satisfies the conditions
described above and must make that determination on the basis of credible
information.
The sponsor of the investigation must notify FDA within 5 days after making
such a change.
Effective: Upon promulgation of a regulation due by November 21, 1998.
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Section 201 - Early Collaboration of Data Requirements for Clinical Studies
Sponsors that intend to perform a clinical study of any Class III device or
any implantable device in any class, will be given an opportunity to meet
with FDA to discuss their investigational plan, including the clinical
protocol, for the purpose of reaching an agreement on the investigational
plan before they apply for an investigational device exemption (IDE).
A written request for this meeting from the sponsor to FDA is required. The
request shall include a detailed description of the device, proposed
conditions of use and a proposed investigational plan (including clinical
protocol), and, if available, expected performance of the device. The FDA
has 30 days to meet with the sponsor after receipt of the written request.
An official record will be made of any agreement that is reached between the
sponsor and the FDA. This agreement will be binding and is not subject to
change except:
1) with written agreement of the sponsor; or
2) if FDA decides that a substantial scientific issue essential to
determining the safety or effectiveness of the device has been identified
following the initial agreement. In this case, the decision by FDA must be
in writing and follow an opportunity for the sponsor to meet with the Agency
to discuss the issue identified.
Effective: February 19, 1998.
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Section 205 - Meeting on Evidence of Effectiveness for PMA’s
Sponsors planning to submit a Premarket Approval Application (PMA) can
submit a written request to FDA for a meeting to determine the type of
information (valid scientific evidence) that is necessary to support the
effectiveness of their device.
The request must include a detailed description of the device, proposed
conditions of use, an investigational plan and, if available, information
regarding the device’s expected performance. The FDA must meet with the
requester and communicate the Agency’s determination of the type of data
that will be necessary to demonstrate effectiveness in writing within 30
days after the meeting. When making this determination, FDA must determine
that the information specified is necessary to provide a reasonable
assurance that the device is effective and must have considered the least
burdensome method of evaluation that is likely to result in approval.
FDA’s determination will be binding and not subject to change unless the
Agency determines that the decision could be contrary to the public health.
While the meeting under Section 205 is intended to focus on the type of
valid scientific evidence that will be necessary and the meeting under
Section 201 is intended to focus on the actual protocol, FDA believes the
purposes of the meetings can usually most effectively be accomplished in a
single meeting. However, some sponsors may request and benefit from two
separate meetings.
Effective: February 19, 1998
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Section 203 - Expanded Humanitarian Device Exemption (HDE)
Approval of Applications
Requires FDA approval or denial of an HDE within 75 days (rather than 180
days) following the receipt of the application. HDEs are no longer limited
to renewable terms of 18 months. The term of the HDE is now indefinite, but
FDA may require a sponsor to demonstrate continued compliance any time:
1) the Agency believes it is necessary to protect public health; or
2) the Agency has reason to believe the criteria for an HDE is not being met.
Approval of an HDE may not be withdrawn unless the sponsor is given an
opportunity for an informal hearing.
Emergency Use
Emergency use by a physician of a device with an approved HDE is permitted
when approval by an Institutional Review Board (IRB) cannot be obtained in
time. Following emergency use, the physician is required to notify the IRB.
The IRB will be provided with the name of the patient, the device used, and
the reason for the use.
Timeframes
The 5 year "sunset" provision limiting the use of HDEs has been removed.
Effective: February 19, 1998
* Section 402 - Expanded Access to Investigational Devices
* This provision also affects other products in addition to medical devices
that are regulated by the FDA. However, any processes or procedures that
CDRH establishes will apply only to medical devices.
Emergency Use
The FDA can permit the shipment of an investigational device for the purpose
of diagnosing, monitoring or treating a serious disease or condition in an
emergency situation.
Individual Patient Access to Investigational Devices
Allows any person, acting through a physician, to request from a
manufacturer or a distributor, an investigational device subject to the
provisions of Section 520(g) of the FFD&C Act to diagnose, treat or monitor
a serious disease or condition, and allows the manufacturer or distributor
to supply the device if the following criteria are met:
1) the licensed physician determines that there is no comparable or
satisfactory alternative treatment and that the risk from use of the device
does not exceed the risk of the disease or condition;
2) the FDA determines there is sufficient evidence of safety and
effectiveness to support the use of the device;
3) the FDA determines that providing the device will not interfere with
clinical investigations to support marketing approval; and
4) the sponsor or investigator submits a protocol to FDA describing the use
of the device in a single patient or in small groups of patients.
Treatment Investigational Device Exemption
Following the submission of a protocol by a physician or sponsor intended to
provide widespread access to an investigational device, the FDA shall
permit treatment use of the device for patients outside the clinical
investigation to support marketing approval, if the Agency determines:
1) the use of the device is intended for the diagnosis, monitoring or
treatment of a serious or immediately life-threatening disease or condition;
2) there is no comparable or satisfactory alternative;
3) the device is being clinically evaluated under an approved
investigational device exemption or all clinical investigations to support
marketing approval have been completed;
4) the sponsor is actively pursuing marketing approval;
5) the treatment use will not interfere with the enrollment of patients in
ongoing clinical investigations;
6) for serious diseases there is sufficient evidence of safety and
effectiveness to support treatment use; and
7) for immediately life-threatening diseases the available scientific
evidence, taken as a whole, provides a reasonable basis to conclude that the
device may be effective in treatment use and would not put patients at an
unreasonable risk.
The FDA may inform national, state and local medical associations and other
appropriate persons of the availability of the investigational device for
treatment use.
The FDA may terminate expanded access under this section if the conditions
under this section are no longer being met.
Effective: February 19, 1998
Section 214 - Practice of Medicine
Nothing in this Act limits or interferes with the authority of a physician
to prescribe or administer any legally marketed device to treat any disease
or condition if done within a legitimate health care practitioner-patient
relationship. However, FDA retains its current authority to restrict the
sale, distribution, or labeling of devices and to prohibit the promotion of
unapproved uses.
Effective: February 19, 1998
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Sections Related to Premarket Approval
Section 201 - Data from Previous Investigations
Section 202 - Special Review for Certain Devices
Section 205 - Scope of Review/Collaborative Determinations of Device Data
Requirements
Section 207 - Risk Based Classification of Postamendment Class III Devices
Section 208 - Classification Panels
Section 209 - For PMA Collaborative Review Process
Section 216 - Use of Data
Section 216 - Product Development Protocol (PDP)
Section 217 - Clarification of the Number of Required Clinical
Investigations for Approval
Section 403 - Approval of Supplemental Applications
Section 201 - Data from Previous Investigations
Allows for the submission of data from investigations of earlier versions of
a device in support of safety and effectiveness. Such data is only valid if
modifications to earlier versions of the investigational device, whether
made during or after the investigation, do not constitute a significant
change that would invalidate the relevance of the data. In addition, this
section allows for the submission of data or information relating to an
approved device that are relevant to the design and intended use of a device
for which an application is pending, provided the data are available for
use under the FFD&C Act. (i.e. available by right of reference or in the
public domain)
Effective: February 19, 1998
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Section 202 - Special Review for Certain Devices
The FDA will provide special review, which can include expedited processing
of a Premarket Approval (PMA) application, for certain devices intended to
treat or diagnose life threatening or irreversibly debilitating diseases or
conditions. To receive special review, the devices must meet one of the
following criteria:
1) the device represents a breakthrough technology;
2) there are no approved alternatives;
3) the use of the device offers significant advantages over existing
approved alternatives; or
4) availability is in the best interest of the patients.
Effective: February 19, 1998
Section 205 - Scope of Review/Collaborative Determinations of Device Data
Requirements
Labeling Claims for PMA’s
The FDA is to rely on the conditions of use submitted as proposed labeling
in the PMA application, so long as the proposed labeling is neither false
nor misleading. In determining whether or not such labeling is false or
misleading, FDA shall fairly evaluate all material facts pertinent to the
proposed labeling. This provision is consistent with the way FDA has always
reviewed PMAs.
Effective: February 19, 1998
Notices/PMA Supplements for Manufacturing Changes
PMA supplements are required for all changes that affect safety or
effectiveness, unless such change involves modifications in a manufacturing
procedure or method of manufacturing. Manufacturing changes affecting safety
or effectiveness may require only a written notice to FDA, which describes
the changes in detail and which summarize the information that supports the
change. The written notice must also state that the changes were made in
accordance with the Quality Systems Regulation (GMPs). The devices subject
to manufacturing changes can be distributed 30 days after a notification
report is submitted to FDA unless the Agency notifies the submitter that the
notice is not adequate.
If FDA deems the notice to be inadequate, FDA may request further
information or require a PMA supplement. The FDA shall review the supplement
within 135 days of receipt. The initial 30 day notification review period
will be deducted from the 135 day supplement review period if the original
notification meets the appropriate content requirements for a PMA supplement.
This notification procedure applies only to supplements relating to changes
in manufacturing procedures or methods.
Effective: February 19, 1998
PMA Supplements for Design Changes
PMA supplements for incremental changes in design affecting safety and
effectiveness can be approved based on:
1) non-clinical data that demonstrate the change creates the intended
additional capacity, function, or performance of the device; and
2) clinical data included in the original PMA application or any supplement
to that application that provides reasonable assurance of safety and
effectiveness.
However, if needed, FDA may require a sponsor to submit new clinical data to
demonstrate safety and effectiveness.
Effective: February 19, 1998
Postmarket Controls to Reduce Data Requirements
While making a determination regarding the approval of a PMA application,
FDA must consider if postmarket controls can be relied on to reduce the
extent of data pertaining to effectiveness that otherwise would be required
to support approval.
Effective: February 19, 1998
Section 207 - Risk Based Classification of Postamendment Class III Devices
An applicant who submits a Premarket Notification Submission [510(k)] and
receives a Not Substantially Equivalent (NSE) determination, placing the
device into a Class III category, can request FDA to classify the product
into Class I or II.
The request must be in writing and sent within 30 days from the receipt of
the NSE determination. In addition, the request must include a description
of the device, reasons for the recommended classification (into Class I or
II), and information to support the recommendation. Within 60 days from the
date the written request is submitted to FDA, the Agency must classify the
device by written order.
If FDA classifies the device into Class I or II, this device can be used as
a predicate device for other 510(k)s.
However, if FDA determines that the device will remain in Class III, the
device cannot be distributed until the applicant has obtained an approved
Premarket Approval (PMA) application or an approved Investigational Device
Exemption (IDE).
Within 30 days of notifying the applicant of the determination that the
device has been classified into Class I or Class II, FDA will announce the
final classification in the Federal Register.
Effective: February 19, 1998
Section 208 - Classification Panels
Scheduling of Meetings
Meetings shall be scheduled so that the FDA timeframes for approval of PMA
and 510(k) applications can be met.
Review by the Panel
PMA applicants shall have:
1) the same access as FDA to data and information submitted by FDA to a
classification panel, except data not available for public disclosure;
2) the opportunity to submit information based on the PMA, through FDA, to
the panel; and
3) the same opportunity as FDA to participate in panel meetings.
Final Decision
If the final decision to approve or disapprove an application differs from
the panel recommendation, reasons for this determination shall be provided
to the applicant in writing by FDA.
Effective: February 19, 1998
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Section 209 - For PMA Collaborative Review Process
The FDA must, upon the written request of the applicant, meet with that
party within 100 days of receipt of the filed PMA application to discuss the
review status of the application. With the concurrence of the applicant, a
different schedule may be established.
Prior to this meeting, FDA must inform the applicant in writing of any
identified deficiencies and what information is required to correct those
deficiencies. The FDA must also promptly notify the applicant if FDA
identifies additional deficiencies or of any additional information required
to complete Agency review.
Effective: February 19, 1998
Section 216 - Use of Data
The FDA can now use certain information, contained in approved PMA
applications, six years after the application has been approved to:
1) approve another PMA application;
2) determine whether a Product Development Protocol (PDP) has been completed;
3) establish a performance standard or a special control; or
4) classify or reclassify another device.
Information available for the Agency to use would include clinical and non-
clinical tests or studies in the application that were used to demonstrate
safety and effectiveness. However, it would exclude trade secret information
such as manufacturing methods or device composition.
Effective: February 19, 1998
Section 216 - Product Development Protocol (PDP)
The FDA is no longer required to refer all PDP’s to panel. The Agency now
has discretion to refer a proposed protocol to an advisory panel for
recommendation regarding approval before making a determination. However,
FDA is required to refer the proposed protocol to the panel if requested by
the submitter, unless the protocol and accompanying data substantially
duplicate information that has been reviewed by the panel previously.
Effective: February 19, 1998
Section 217 - Clarification of the Number of Required Clinical
Investigations for Approval
The FDA can rely on one or more clinical investigations to conclude that a
device that is the subject of a PMA application is effective or to establish
a device performance standard.
Effective: February 19, 1998
Section 403 - Approval of Supplemental Applications
Standards for Prompt Review
The FDA will publish, in the Federal Register (FR), standards the Agency
will use to assure prompt review of a PMA supplement.
Effective: FR notification due by May 20, 1998
Guidance to Industry
The FDA will publish final guidance to clarify the requirements for, and
facilitate the submission of, data to support a PMA supplement. This
guidance will:
1) clarify when published information can be used as the basis of approval;
2) specify data requirements that will avoid duplication of previously
submitted data used to support the original PMA application; and
3) identify types of supplements that are eligible for priority review.
Effective: Guidance due by May 20, 1998
Designated Individual
A person will be designated from the Center for Devices and Radiological
Health to encourage prompt review of supplements by FDA and to work with
sponsors to facilitate both the development and submission of data necessary
to support a PMA supplement.
Effective: February 19, 1998
Collaboration with Outside Organizations
The FDA will implement programs and policies to foster collaboration with
outside organizations, including the National Institutes of Health, medical
and scientific associations, and others for purposes of identifying studies
that may support PMA supplements and to encourage sponsors to make
supplemental applications or conduct further research to support supplements.
Effective: February 19, 1998
Sections Related to Premarket Notification [510(k)]
Section 205 - Collaborative Determinations of Device Data Requirements
Section 206 - Premarket Notification
Section 209 - Certainty of Review Timeframes
Section 210 - Accreditation of Persons for Review of Premarket Notification
Reports
Section 205 - Collaborative Determinations of Device Data Requirements
Postmarket Controls to Reduce Data Requirements
While making a determination regarding the clearance of a [510(k)]
application, FDA must consider if postmarket controls can be relied on to
expedite such clearance.
Effective: February 19, 1998
Additional Information
When FDA requests additional information to demonstrate equivalence for
devices that have different technological characteristics than the predicate
, FDA shall only request information necessary to make a determination of
substantial equivalence and shall consider the least burdensome means of
demonstrating substantial equivalence.
Effective: February 19, 1998
Labeling Claims for 510(k)’s
This section requires that a determination about the intended use of a
device be based on the proposed labeling submitted in the 510(k) application
. In making the determination, however, the Director of the Office of Device
Evaluation (ODE) may determine that there is a reasonable likelihood that
the device will be used for an intended use not identified in the labeling
that could cause harm. In such cases, the Director shall communicate FDA’s
concerns to the 510(k) applicant in writing within 10 days of making the
determination and require a statement in the labeling specifying limitations
on uses of the device.
The device will be found substantially equivalent if it otherwise meets the
requirements for substantial equivalence and if its labeling conforms to the
limitations specified by FDA. Responsibility for making such labeling
determinations cannot be delegated below the Director of the Office of
Device Evaluation (ODE).
Effective: February 19, 1998
Sunset clauses: Expires November 21, 2002
Na name="206premarket">Section 206 - Premarket Notification
Exemption from 510(k)
A 510(k) submission is not required for a Class I device unless the Class I
device:
1) is intended for a use which is of substantial importance in preventing
impairment of human health; or
2) presents a potential unreasonable risk of illness or injury.
A 510(k) submission will not be required for specified Class II devices. The
FDA plans to publish in the Federal Register, within 60 days of enactment
of the Modernization Act, a list of Class II devices that are exempt from
510(k).
After the list of Class II exempt devices has been published, additional
Class II devices may be exempted on FDA’s own initiative or by petition of
an interested person. The FDA will publish in the Federal Register a notice
of intent to exempt these device types and provide a 30 day period for
comment. Within 120 days after the issuance of the notice, FDA will publish
a final order regarding the exemption of the subject devices. If FDA fails
to respond to a petition within 180 days, it will be deemed granted.
Effective: January 20, 1998 upon publication of 510(k) exempt Class II
devices.
Substantial Equivalence
The FDA cannot withhold a 510(k) decision for failure of a firm to comply
with any provision of the FFD&C Act unrelated to a substantial equivalence
decision, including failure by the firm manufacturing the device to comply
with GMPs, unless, FDA finds that failure to comply with such regulations
will potentially present a serious risk to human health.
Effective: February 19, 1998
General/Specific Uses
The FDA will publish guidance within 270 days of enactment specifying
general principles it will follow for determining when a specific intended
use is not reasonably included within a general use for the purpose of
determining substantial equivalence.
Effective: Guidance due by August18, 1998.
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Section 209 - Certainty of Review Timeframes
The law directs FDA to review premarket notifications and make a
determination not later than 90 days after receiving the report.
Effective: February 19, 1998
Section 210 - Accreditation of Persons for Review of Premarket Notification
Reports
Background
The FDA is authorized to expand the scope of the existing Third Party 510(k)
review program. The FDA must accredit persons to conduct initial 510(k)
reviews no later than one year after enactment. Accredited persons may not
review:
1) Class III devices;
2) Class II devices that are permanent implants or life sustaining or life
supporting; or
3) Class II devices which require clinical data, except the number in this
group must not be more than 6% of total submissions (as defined by statute).
Following review by an accredited party, FDA must act within 30 days of
receipt of the accredited party’s recommendation to accept the
recommendation or change the classification of the device. If FDA changes
the recommendation, it will notify the applicant and the third party
explaining in detail the reasons for the change.
Accreditation
By May 20, 1998, FDA will publish in the Federal Register criteria it will
use to accept or deny accreditation to persons who submit requests to
perform reviews. The FDA must respond to a request for accreditation within
60 days of receipt.
The FDA may suspend or withdraw accreditation after providing notice and
opportunity for an informal hearing when the accredited body:
1) is substantially not in compliance with this section;
2) poses a threat to public health; or
3) fails to act in a manner consistent with the purposes of this section.
The FDA must make periodic onsite visits to accredited persons to audit
performance and has access to and authority to copy and verify records.
Minimum qualifications of accredited persons include:
1) shall not be a Federal Government employee;
2) must be an independent organization not owned or controlled by a
manufacturer, supplier or vendor of devices and have no organizational,
material, or financial affiliation with such a manufacturer, supplier or
vendor;
3) must be a legally constituted entity permitted to act as a third party;
4) shall not engage in design, manufacture, promotion or sale of devices;
5) operate in accordance with generally accepted professional and ethical
business practices and agree in writing that at a minimum it will:
(i) certify that reported information accurately reflects data reviewed;
(ii) limit work to that for which competence and capacity are available;
(iii) treat information received, records, reports, and recommendations as
proprietary information;
(iv) promptly respond and attempt to resolve complaints regarding its
activities for which it is accredited; and
(v) protect against the use of officers or employees to conduct reviews when
that person has a financial conflict of interest regarding the device, and
annually disclose in a public report the extent to which officers and
employees have maintained compliance with requirements relating to financial
conflicts of interest.
Effective: May 20, 1998 (publish criteria to accredit persons)
Records Required of Third Parties
Accredited parties must maintain records:
1) documenting the training qualifications of all employees associated with
conducting reviews;
2) documenting the procedures used by the employees for handling
confidential information; and
3) documenting the compensation arrangements and procedures used to identify
and avoid conflicts of interest.
These records are available upon request to FDA at all reasonable times and
may be viewed, copied, or verified. Within 15 days of receipt of a written
request from FDA, the accredited party shall make available copies of the
requested records at the place designated by FDA.
It is a prohibited act for an accredited party to:
1) submit a report that is false or misleading;
2) disclose confidential information or trade secrets without the submitter
’s consent; and
3) receive bribes or perform a corrupt act.
Access to Accredited Persons
The FDA must provide each person who wishes to use an accredited person a
panel of at least two accredited bodies from which to choose. Compensation
for the review will be based on agreement between the parties.
Progress Reports to Congress
Required reports include:
1) an annual FDA report to Congress that includes the names of all
accredited persons, the activities they are accredited to perform, and the
name of each body whose accreditation has been withdrawn.
2) an FDA report to Congress, to be published in the Federal Register no
later than November 21, 2000, addressing whether the limitation on
accredited body review of Class II devices requiring clinical data should be
removed.
3) a Comptroller General report to Congress describing the extent to which
the accreditation program has been implemented, not later than November 21,
2002.
4) a Comptroller General evaluation report to Congress describing the extent
to which use of accredited bodies assisted the Agency in reviewing 510(k)’
s and the extent to which such use was contrary to the purposes of the Act,
not later than 6 months before the program terminates.
Authority for the program terminates:
1) 5 years after at least 2 accredited parties are available to do 60% of
the 510(k) reviews; or
2) 4 years after accredited bodies have reviewed 35% of eligible 510(k)’s,
whichever occurs first.
Effective: November 21, 1998 (accredit persons to review 510(k) reports)
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Sections Related to Device Classification
Note: Sections 206 and 207 include provisions for the classification of
Class II and Class III devices. Section 206 contains requirements that
exempt certain Class I and II devices from Premarket Notification. Section
207 contains a requirement that allows for classification of new, low risk
Class III devices. These provisions are addressed in the Premarket
Notification (Section 206) and Premarket Approval (Section 207) portions of
this document.
Section 416 - Product Classification (Combination Products)
Any person who submits an application or submission for a product may
recommend to FDA a classification for the product or the component of FDA
the applicant believes to be most appropriate to regulate the product. The
request can recommend classifying the product as a drug, biological product,
device, or a combination product under Section 503(g) of the FFD&C Act.
Not later than 60 days after receipt of the request, FDA must determine the
classification or the component that will regulate the product, and must
provide a written statement to the requester that identifies the
classification or component and the reasons for the determination. The
written statement cannot be changed without consent of the requester or for
public health reasons based on scientific evidence. If FDA does not respond
within 60 days, the requester’s recommendation becomes the final FDA
determination and cannot be changed without the written consent of the
requester or for public health reasons based on scientific evidence.
Effective: February 19, 1998
Sections Related to Device Labeling
Section 401 - Dissemination of Information on New Uses
Section 421 - Labeling and Advertising Regarding Compliance with Statutory
Requirements
Manufacturers may disseminate written information concerning the safety,
effectiveness, or benefit of a use not described in a device’s approved
labeling to health care practitioners, pharmacy benefit managers, health
insurance issues, group health plans, or Federal or State agencies provided
the following requirements are satisfied:
the device is a legally marketed device;
the information is not derived from clinical research conducted by another
manufacturer, unless the manufacturer disseminating the information has
permission to use the information;
sixty (60) days prior to disseminating the information, the manufacturer
submits to FDA a copy of the information and any clinical trial information
the manufacturer has relating to the safety or effectiveness of the new use,
any reports of clinical experience that pertain to safety of the new use,
and a summary of such information;
the manufacturer has complied with the requirements (discussed below)
relating to a supplemental application for such use; and
information on the new use is not false or misleading, does not pose a
significant risk to public health, and is in the form of:
1) unabridged reprints or copies of peer-reviewed, scientifically sound
articles published in scientific or medical journals about clinical
investigations involving the device; or
2) reference publications that include information about clinical
investigations.
The manufacturer includes with the information to be disseminated a
prominently displayed statement disclosing:
1) that the use is not approved or cleared by FDA;
2) if applicable, that the information is being disseminated at the expense
of the manufacturer;
3) if applicable, the names of any authors of the information who are
employees or consultants to the manufacturer or have received compensation
or have a financial interest in the manufacturer;
4) the official labeling and all updates;
5) if applicable, a statement that there are products or treatments that
have been approved or cleared for the use that is the subject of the
information; and
6) the identification of any person that has provided funding for the study
related to the new use.
the manufacturer includes a bibliography of other articles from scientific
reference publications or journals relating to the use that is the subject
of the information.
if FDA determines that the manufacturer fails to provide data, analyses or
other written matter that is objective and balanced, FDA may require the
manufacturer to disseminate additional objective and scientifically sound
information that pertains to the safety and effectiveness of the use that is
the subject of the information and an objective statement of FDA that bears
on the safety or effectiveness of the new use.
And:
the manufacturer has submitted a supplemental application for such use;
Or:
in the case of a completed study, the manufacturer submits to FDA an
application containing a certification that the studies needed for a
supplemental application for the new use are completed and the supplemental
application will be submitted within 6 months after the initial
dissemination of information on the new use;
Or:
in the case of a planned study, the manufacturer submits an application to
FDA containing a proposed protocol and schedule for conducting the studies
needed for the supplemental application for the new use and a certification
that the supplemental application will be submitted not later than 36 months
after the initial dissemination of information on the new use;
Or:
the manufacturer submits to FDA an application for an exemption from
submission of a supplemental application, and such exemption is granted.
Manufacturers have an ongoing responsibility to provide FDA with new
information about the new use and if this new information indicates that the
use may present a significant risk to public health, FDA may order
cessation of the dissemination of information about the use.
The FDA may also order cessation of dissemination if the manufacturer fails
to comply with the requirements for dissemination, including the
requirements relating to the submission of a supplemental application. The
Agency can, except in limited circumstances, also require the manufacturer
to take corrective action when it orders the cessation of dissemination.
Manufacturers are required to prepare and submit to FDA lists of titles of
articles and publications that have been disseminated and the categories of
providers that have received the materials. In addition, manufacturers must
keep records which can be used by the manufacturer or FDA to take corrective
action.
It is a prohibited act to disseminate information in violation of the
requirements of this section.
Effective: November 21, 1998 or upon issuance of a final regulation,
whichever is sooner.
Sunset: Expires September 30, 2006 or 7 years after issuance of final
regulation, whichever is later.
Section 421 - Labeling and Advertising Regarding Compliance with Statutory
Requirements
Repeals the restriction in Section 301(l) of the Federal Food, Drug and
Cosmetic (FFD&C) Act, which prohibits reference to FDA approval in the
labeling or advertising of medical devices that have an approved PMA or IDE.
Effective: February 19, 1998
Section Related to Device Tracking
Section 211 - Device Tracking
The tracking requirement has been changed to eliminate automatic mandatory
tracking for certain devices. The new law gives FDA discretion to order
manufacturers of certain types of Class II or Class III devices to initiate
a program to track their medical devices down to the patient level. The
illustrative list that has been published in 21 CFR 821 will be replaced
with a list of products that FDA has ordered to be tracked.
The types of devices subject to a tracking order may include any Class II or
Class III device:
the failure of which would be reasonably likely to have serious adverse
health consequences:
which is intended to be implanted in the human body for more than one year;
or
which is intended to be a life sustaining or life supporting device used
outside a device user facility.
The Modernization Act also allows patients receiving a tracked device to
refuse to release, or refuse permission to release, their name, address,
social security number, or other identifying information for the purpose of
tracking.
The FDA plans to contact manufacturers of devices that have previously been
identified as devices subject to tracking to indicate whether they should
continue to track these devices or if tracking may be discontinued.
Manufacturers currently required to track devices under Section 519(e) of
the FFD&C Act should not discontinue tracking prior to communication from
FDA.
Effective: February 19, 1998
Section Related to Postmarket Surveillance
Section 212 - Postmarket Surveillance
Manufacturers will no longer be automatically required to conduct postmarket
surveillance studies for particular devices. Rather, FDA may order such
studies to be conducted for certain Class II and Class III devices. The FDA
can now order postmarket surveillance for any Class II and Class III device:
the failure of which would be reasonably likely to have serious adverse
health consequences; or
which is intended to be implanted in the human body for more than one year;
or
which is intended to be a life sustaining or life supporting device used
outside a device user facility.
Manufacturers must, within 30 days of receiving an order to conduct a
postmarket surveillance study from FDA, submit, for approval, a plan for the
required surveillance. The FDA may order a study for up to 36 months. Any
longer period has to be mutually agreed upon by the manufacturer and FDA. If
no agreement on a longer time period can be reached, then a dispute
resolution process is to be followed.
After receiving the manufacturer’s proposed plan, FDA has 60 days to
determine if the person designated to conduct the surveillance is qualified
and experienced, and if the plan will collect useful data that can reveal
unforeseen adverse events or other information necessary to protect the
public health.
All postmarket surveillance studies ordered under Section 522 of the FFD&C
Act should continue at this time. The FDA plans to individually contact the
manufacturers currently conducting postmarket surveillance studies to
confirm whether the ongoing studies should be completed.
Effective: February 19, 1998
Section Related to Global Harmonization
Section 410 - Mutual Recognition Agreements and Global Harmonization
Good Manufacturing Practices
The FDA shall ensure that the Quality Systems Regulation (Good Manufacturing
Practices) conforms to the extent practicable with all or part of
internationally recognized standards defining quality systems.
By May 20, 1998, FDA shall make public a plan that establishes a framework
for achieving mutual recognition of Good Manufacturing Practices (GMP’s)
inspections.
U.S. Trade Representatives
The FDA is directed to support the Office of the U.S. Trade Representative (
USTR) by:
1) meeting with representatives of other countries to discuss methods to
reduce the burden of regulation and harmonize regulatory requirements,
consistent with consumer protection; and
2) engaging in efforts to move toward acceptance of Mutual Recognition
Agreements (MRA’s) relating to the regulation of devices and GMP’s between
the European Union and the U.S.
Meetings
The FDA is directed to regularly participate in meetings with
representatives of other foreign governments to discuss and reach an
agreement on methods and approaches to harmonize regulatory requirements.
Effective: February 19, 1998
Effective: May 20, 1998 (publication of plan for mutual recognition of GMP)
Sections Related to Medical Device Reporting and Recall Reports
Section 213 - Medical Device Reporting
Section 420 - Safety Report Disclaimers
Section 213 - Medical Device Reporting
Distributors
Distributors of medical devices are no longer required to report device
related adverse events involving death, serious injury and malfunction to
the FDA and/or the device manufacturer. Instead, distributors must keep
records of complaints and make the records available to FDA upon request.
Effective: February 19, 1998
Annual Certification Requirement
Repeals the requirement for manufacturers, importers and distributors to
submit an annual certification, Form FDA 3381, to FDA certifying whether any
adverse event reports were filed during the previous year and, if so, the
number filed.
Effective: February 19, 1998
User Facilities
The user facility semi-annual reporting requirement has been changed to
annual reporting. The annual report will now be due on January 1 of each
year. User facilities may continue to use the current semi-annual user
facility report form, FDA 3419, until a revised one is issued by FDA.
The identity of user facilities that are submitting MDR reports is protected
from disclosure except in connection with:
1) certain actions brought to enforce device requirements under the FFD&C
Act; or
2) a communication to a manufacturer of a device that is the subject of a
report to FDA of death, serious illness or injury, or other significant
adverse experience. Effective: February 19, 1998
Sentinel System for User Facilities
The FDA is directed to promulgate a regulation and implement a program under
which the FDA limits user reporting to a subset of user facilities that
constitutes a representative profile of user reports for device related
deaths and serious illnesses or serious injuries. The program is called the
"Sentinel System." Until such regulation is promulgated, all user facilities
continue to be subject to the current requirements of the Medical Device
Reporting (MDR) regulation, 21 CFR 803. No later than November 21, 1999, FDA
is directed to submit a plan to Congress to limit user reporting and a
progress report on its implementation.
Effective: Upon promulgation of regulation.
Reports of Removals and Corrections
Repeals the requirement for reporting by distributors of any removal or
correction of a device undertaken to reduce a risk to health posed by the
device or to remedy a violation of the FFD&C Act that may present a risk to
health. The requirement will still apply to manufacturers and importers.
Effective: February 19, 1998
Section 420 - Safety Report Disclaimers
The submission of a safety report on a medical device shall not be
interpreted as a conclusion by the person making the submission or by the
FDA that the report constitutes an admission that the product malfunctioned,
caused or contributed to an adverse experience, or otherwise caused or
contributed to a death, serious injury, or serious illness.
Effective: February 19, 1998
Sections Related to Establishment Registration
Section 213 - Exemption of Wholesale Distributors from Establishment
Registration
Section 417 - Registration of Foreign Establishments
Section 213 - Exemption of Wholesale Distributors from Establishment
Registration
Wholesale distributors of devices, who do not manufacture, repackage,
process, or relabel a device, are no longer required to register their
establishment with the FDA.
A "wholesale distributor" is defined as any person (other than the
manufacturer or the initial importer) who distributes a device from the
original place of manufacture to the person who makes the final delivery or
sale of the device to the ultimate consumer or user.
Effective: February 19, 1998
Section 417 - Registration of Foreign Establishments
Foreign establishments engaged in the manufacture, preparation, propagation,
compounding, or processing of a device that is imported, or offered for
import, into the U.S. must register their establishments and provide the FDA
with the name of the U.S. agent representing their establishment. Foreign
establishments must also continue to provide FDA with a list of the devices
that they are exporting to the U.S. FDA is also authorized to enter into
cooperative agreements with foreign countries to ensure that non-compliant
products are refused entry into the U.S.
Effective: February 19, 1998
Section Related to Device Standards
Section 204 - Device Standards
This section adds a system for recognizing national and international
standards in product reviews. The FDA may, through publication in the
Federal Register, recognize all or part of an appropriate standard
established by a nationally or internationally recognized standards
development organization.
A person may reference the recognized standard in a Declaration of
Conformity, which can be used to satisfy a premarket submission requirement
[PMA or 510(k)] or other requirement under the FFD&C Act to which such a
standard applies. The FDA can request supportive data. The FDA may reject
the declaration if information supplied does not demonstrate that the device
conforms to the standard, or if the standard is inapplicable.
The FDA may withdraw such recognition of a standard, through publication of
a notice in the Federal Register, if the Agency determines that the standard
is no longer appropriate for meeting a requirement.
The FDA may take action against a firm if information in the Declaration of
Conformity is falsified, or for failure or refusal to provide data or
information requested by FDA.
Effective: February 19, 1998
Other Sections Related to Medical Devices
Section 404 - Dispute Resolution
Section 405 - Informal Agency Statements
Section 418 - Clarification of Seizure Authority
Section 404 - Dispute Resolution
This requires the FDA to establish, by regulation, a process under which a
sponsor, applicant, or manufacturer may request a review of a significant
scientific controversy, including a review by an appropriate scientific
panel or advisory committee, when no other provision of the FFD&C Act or
regulation provides for such a review.
The Center plans to distribute a guidance for assisting the industry in
identifying the most appropriate course of action for resolving various
types of complaints.
Effective: November 21, 1998
Section 405 - Informal Agency Statements
The FDA shall develop guidance documents with public participation and make
these documents publicly available both in written form and, as feasible,
through electronic means.
The FDA will train employees in how to develop and use guidance documents
and will monitor the development and issuance of such documents.
In developing guidance documents, FDA will ensure uniform nomenclature and
internal review procedures and update and publish a list of these documents
in the Federal Register. Neither FDA nor the public will be bound by the
guidance documents; however, FDA will ensure that its employees do not
deviate from such guidance without appropriate justification and supervisory
concurrence.
FDA will obtain public participation prior to implementation of guidance
documents that set forth initial interpretations of a statute or regulation,
changes in interpretation or policy that are of more than a minor nature,
complex scientific issues, or highly controversial issues unless FDA
determines that prior public participation is not feasible or appropriate.
In such cases where prior public participation is not feasible or
appropriate, or in instances where the guidance document sets forth existing
policy or minor changes, FDA will solicit public comment upon
implementation.
The FDA will develop an appeals mechanism to deal with complaints regarding
development and use of guidance documents.
Effective: February 19, 1998
Effective: July 1, 2000 (issue regulation on policy/procedures for
development, issuance and use of guidance documents)
Section 418 - Clarification of Seizure Authority
Any person seeking release of an imported article condemned under Section
304(d)(1) of the FFD&C Act must establish that the product was intended for
export at the time it entered the United States.
Effective: February 19, 1998 | l*****f
发帖数: 359 | 2 this is the longest article on this board
orz
【在 s**********8 的大作中提到】
: Overview of FDA Modernization Act of 1997, Medical Device Provisions
: CDRH FDA Modernization Act of 1997 Page1
: Foreword
: Preface
: Introduction
: Investigational Device Exemptions
: Premarket Approval
: Premarket Notification [510(k)]
: Device Classification
: Device Labeling
| s**********8
发帖数: 25265 | 3 u read all of them?
【在 l*****f 的大作中提到】
: this is the longest article on this board
: orz
| l*****f
发帖数: 359 | 4 wanna test?
【在 s**********8 的大作中提到】
: u read all of them?
| s**********8
发帖数: 25265 | 5 真看了? 你傻啊你.
【在 l*****f 的大作中提到】
: wanna test?
| l*****f
发帖数: 359 | 6 ......
did u just realized that :P
【在 s**********8 的大作中提到】
: 真看了? 你傻啊你.
| R**********s
发帖数: 4627 | 7 这个孩子，上贼船了
【在 s**********8 的大作中提到】
: 真看了? 你傻啊你.
| s**********8
发帖数: 25265 | 8 痴呆了.
【在 R**********s 的大作中提到】
: 这个孩子，上贼船了
| R**********s
发帖数: 4627 | 9 帅不帅?
能不能用潜规则治疗法?
【在 s**********8 的大作中提到】
: 痴呆了.
| l*****f
发帖数: 359 | 10 :(
【在 s**********8 的大作中提到】
: 痴呆了.
| | | l*****f
发帖数: 359 | 11 有帅哥证
【在 R**********s 的大作中提到】
: 帅不帅?
: 能不能用潜规则治疗法?
| R**********s
发帖数: 4627 | 12 多少钱买的?
【在 l*****f 的大作中提到】
: 有帅哥证
| l*****f
发帖数: 359 | 13 自己做的,不花钱
【在 R**********s 的大作中提到】
: 多少钱买的?
| R**********s
发帖数: 4627 | 14 你就表掩饰了
手巧的人必然貌丑
【在 l*****f 的大作中提到】
: 自己做的,不花钱
| s**********8
发帖数: 25265 | 15 not true. 额就心灵手巧.
【在 R**********s 的大作中提到】
: 你就表掩饰了
: 手巧的人必然貌丑
| R**********s
发帖数: 4627 | 16 以勤补丑嘛
我就是从你身上得出结论的
你很成功
【在 s**********8 的大作中提到】
: not true. 额就心灵手巧.
| l*****f
发帖数: 359 | 17 lol
姑娘,相由心生,古之人不余欺也
【在 R**********s 的大作中提到】
: 你就表掩饰了
: 手巧的人必然貌丑
| S****u
发帖数: 3092 | 18 哈哈哈你乐死我了
【在 R**********s 的大作中提到】
: 帅不帅?
: 能不能用潜规则治疗法?
| l*****f
发帖数: 359 | 19 不可能,俺老师一看就知道很帅
【在 R**********s 的大作中提到】
: 以勤补丑嘛
: 我就是从你身上得出结论的
: 你很成功
| s**********8
发帖数: 25265 | 20 房事勤
【在 R**********s 的大作中提到】
: 以勤补丑嘛
: 我就是从你身上得出结论的
: 你很成功
| | | R**********s
发帖数: 4627 | 21 low le
--cengceng or paopao ?
【在 S****u 的大作中提到】
: 哈哈哈你乐死我了
| l*****f
发帖数: 359 | 22 老师俺前面问你那个关于FDA Medical Device Innovation Initiative的帖子
您还没回呢
房事勤
【在 s**********8 的大作中提到】
: 房事勤
| R**********s
发帖数: 4627 | 23 你是个好娃娃
你老师比你想象的坚强
他已经很坦然的接受事实了
【在 l*****f 的大作中提到】
: 不可能,俺老师一看就知道很帅
| s**********8
发帖数: 25265 | 24 不懂啊. 额有空放狗.
【在 l*****f 的大作中提到】
: 老师俺前面问你那个关于FDA Medical Device Innovation Initiative的帖子
: 您还没回呢
:
: 房事勤
| S****u
发帖数: 3092 | 25 今天还长高了点呐，我羞愧地说
【在 R**********s 的大作中提到】
: low le
: --cengceng or paopao ?
| l*****f
发帖数: 359 | 26 啊,你要是没听说过,那就不放也罢
很多Federal program常常有名无实啦
不懂啊. 额有空放狗.
【在 s**********8 的大作中提到】
: 不懂啊. 额有空放狗.
| s**********8
发帖数: 25265 | 27 神姐姐好幽默
【在 S****u 的大作中提到】
: 今天还长高了点呐，我羞愧地说
| s**********8
发帖数: 25265 | 28 公司大了, 就已经有自己得一套做法. all info are good. let me check it out
【在 l*****f 的大作中提到】
: 啊,你要是没听说过,那就不放也罢
: 很多Federal program常常有名无实啦
:
: 不懂啊. 额有空放狗.
| l*****f
发帖数: 359 | 29 真的吗? 俺还是不信
网上传言他是买买提十大帅哥之一呀
【在 R**********s 的大作中提到】
: 你是个好娃娃
: 你老师比你想象的坚强
: 他已经很坦然的接受事实了
| l*****f
发帖数: 359 | 30 其实我对FDA的运作更感兴趣。。
they are so infamous. is it true?
【在 s**********8 的大作中提到】
: 公司大了, 就已经有自己得一套做法. all info are good. let me check it out
| | | s**********8
发帖数: 25265 | 31 事实总是这么残酷
【在 R**********s 的大作中提到】
: 你是个好娃娃
: 你老师比你想象的坚强
: 他已经很坦然的接受事实了
| s*********e
发帖数: 884 | 32 我查到了，等下发上来，挣个包子，呵呵！
【在 s**********8 的大作中提到】
: 公司大了, 就已经有自己得一套做法. all info are good. let me check it out
| l*****f
发帖数: 359 | 33 谢谢,你心肠真好!
【在 s*********e 的大作中提到】
: 我查到了，等下发上来，挣个包子，呵呵！
| R**********s
发帖数: 4627 | 34 不知道他花了多少钱拉的票
唉
【在 l*****f 的大作中提到】
: 真的吗? 俺还是不信
: 网上传言他是买买提十大帅哥之一呀
| s*********e
发帖数: 884 | 35 不客气，主要是包子的味道好 ：）
【在 l*****f 的大作中提到】
: 谢谢,你心肠真好!
| R**********s
发帖数: 4627 | 36 patpat
不是你的错
男人要名利双收才是王道
看看老养
鸡皮鹤发都有mm爱
【在 s**********8 的大作中提到】
: 事实总是这么残酷
| s**********8
发帖数: 25265 | 37 鸡皮算球啥,鹤发算球啥,就怕缩阳
--杨翁氏
【在 R**********s 的大作中提到】
: patpat
: 不是你的错
: 男人要名利双收才是王道
: 看看老养
: 鸡皮鹤发都有mm爱
| s**********8
发帖数: 25265 | 38 哈哈缩阳算球啥,上器械
--太尉
【在 s**********8 的大作中提到】
: 鸡皮算球啥,鹤发算球啥,就怕缩阳
: --杨翁氏
| s**********8
发帖数: 25265 | 39 灵?
--杨翁氏
【在 s**********8 的大作中提到】
: 哈哈缩阳算球啥,上器械
: --太尉
| s**********8
发帖数: 25265 | 40 凑合着用吧, 总比没有强
--太尉
【在 s**********8 的大作中提到】
: 灵?
: --杨翁氏
| | | s**********8
发帖数: 25265 | 41 tw, 额的再生父母啊
--杨翁氏
【在 s**********8 的大作中提到】
: 凑合着用吧, 总比没有强
: --太尉
| s**********8
发帖数: 25265 | 42 早来啊. 早来早享受
-太尉萎缩地笑,下
【在 s**********8 的大作中提到】
: tw, 额的再生父母啊
: --杨翁氏
|
|
