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发帖数: 25265 | 1 Center for Devices and Radiological Health
From Wikipedia, the free encyclopedia
Jump to: navigation, search
The Center for Devices and Radiological Health (CDRH) is the branch of the
United States Food and Drug Administration (FDA) responsible for the
premarket approval of all medical devices, as well as overseeing the
manufacturing, performance and safety of these devices. The CDRH also
oversees the radiation safety performance of non-medical devices which emit
certain types of electromagnetic radiation, such as cellular phones and
microwave ovens.
The current head of the CDRH is Jeffrey Shuren, who took over in January
2010.
Contents [hide]
1 Regulatory classes
2 History
3 References
4 External links
[edit] Regulatory classes
CDRH splits medical devices into three classes with different regulatory
requirements:
Class 1 devices include everyday items such as toothbrushes which are
unlikely to cause serious consequences if they fail. Manufacturers are
required to follow what are called "general controls" which closely match
ISO 9000 requirements.
In addition to the general controls, Class 2 devices require an approval
that is referred to as a "510(k)" after the relevant section of the Food,
Drug and Cosmetic Act. The intent of this class was for new manufacturers of
devices that already existed when the rules were established. A class 2
device is required to be "substantially equivalent" to existing devices. The
class is now used for "medium risk" devices such as demineralized bone
powder used for reconstructive surgery, which is officially substantially
equivalent to Plaster of Paris, a much older product that was used for the
same purpose. This equivalence is used when the FDA does not think a full
approval process with extensive clinical trials is necessary.
The 501(k) approval process came under fire in February 2011 after the
release of a study by Dr. Diana Zuckerman and Paul Brown of the National
Research Center for Women and Families, and Dr. Steven Nissen of the
Cleveland Clinic, published in the Archives of Internal Medicine. It showed
that most medical devices recalled in the last five years for “serious
health problems or death” had been previously approved by the FDA using the
less stringent, and cheaper, 501(k) process. In a few cases the devices had
been deemed so low-risk that they did not need FDA regulation. Of the 113
devices recalled, 35 were for cardiovacular issues.[1] This may lead to a
reevaluation of FDA procedures and better oversight.[2]
Class 3 devices require a "Pre-market Approval" (PMA), which is analogous to
the drug approval process with clinical trials and extensive review of the
design. Class 3 devices tend to be products such as pacemakers which would
cause obvious risk of injury or death if they did not function properly. As
with all devices, the manufacturers must follow the general controls.
[edit] History
In 1982, when the beginning of the biotechnology revolution blurred the
lines between drugs, biologics, and medical devices, Commissioner Arthur
Hayes reorganized the FDA.[3] This reorganization merged the bureaus
responsible for medical devices and radiation control into their present
form, the Center for Devices and Radiological Health.[3]
[edit] References
^ Zuckerman et al. "Medical Device Recalls and the FDA Approval Process."
Arch Intern Med. 2011; 0: 2011301-6. PMID 21321283
^ Redberg and Dhruva. "Medical Device Recalls: Comment on 'Medical Device
Recalls and the FDA Approval Process.'" Arch Intern Med. 2011; 0: 2011271-2.
PMID 1321286
^ a b Reid, Ken. "CBER and CDER have long history of being lumped together
and split up." Bioresearch Monitoring Alert Sept. 2002. page 4.
[edit] External links
CDRH official government website
Medical Devices
Radiation-Emitting Products
http://en.wikipedia.org/wiki/Center_for_Devices_and_Radiologica
http://www.fda.gov/AboutFDA/CentersOffices/cdrh/default.htm | s**********8
发帖数: 25265 | 2 CDER and CDRH share responsiblities when combo products are concerned.
emit
【在 s**********8 的大作中提到】
: Center for Devices and Radiological Health
: From Wikipedia, the free encyclopedia
: Jump to: navigation, search
: The Center for Devices and Radiological Health (CDRH) is the branch of the
: United States Food and Drug Administration (FDA) responsible for the
: premarket approval of all medical devices, as well as overseeing the
: manufacturing, performance and safety of these devices. The CDRH also
: oversees the radiation safety performance of non-medical devices which emit
: certain types of electromagnetic radiation, such as cellular phones and
: microwave ovens.
| G*********o
发帖数: 49669 | 3 看不懂
勉强re
emit
【在 s**********8 的大作中提到】
: Center for Devices and Radiological Health
: From Wikipedia, the free encyclopedia
: Jump to: navigation, search
: The Center for Devices and Radiological Health (CDRH) is the branch of the
: United States Food and Drug Administration (FDA) responsible for the
: premarket approval of all medical devices, as well as overseeing the
: manufacturing, performance and safety of these devices. The CDRH also
: oversees the radiation safety performance of non-medical devices which emit
: certain types of electromagnetic radiation, such as cellular phones and
: microwave ovens.
| s**********8
发帖数: 25265 | 4 假jj也是器械.
【在 G*********o 的大作中提到】
: 看不懂
: 勉强re
:
: emit
| G*********o
发帖数: 49669 | 5 嗯，你买了？
假jj也是器械.
【在 s**********8 的大作中提到】
: 假jj也是器械.
| s**********8
发帖数: 25265 | 6 卖给老杨了
【在 G*********o 的大作中提到】
: 嗯，你买了？
:
: 假jj也是器械.
| G*********o
发帖数: 49669 | 7 老杨口味很重
卖给老杨了
【在 s**********8 的大作中提到】
: 卖给老杨了
| s**********8
发帖数: 25265 | 8 as always
【在 G*********o 的大作中提到】
: 老杨口味很重
:
: 卖给老杨了
| m********e
发帖数: 2059 | 9 hmmm... interesting...haha... |
|
