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MedicalDevice版 - Combination Product
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1 (共1页)
s**********8
发帖数: 25265
1
Combination Product Definition
Combination products are defined in 21 CFR 3.2(e). The term combination
product includes:
(1) A product comprised of two or more regulated components, i.e., drug/
device, biologic/device, drug/biologic, or drug/device/biologic, that are
physically, chemically, or otherwise combined or mixed and produced as a
single entity;
(2) Two or more separate products packaged together in a single package or
as a unit and comprised of drug and device products, device and biological
products, or biological and drug products;
(3) A drug, device, or biological product packaged separately that according
to its investigational plan or proposed labeling is intended for use only
with an approved individually specified drug, device, or biological product
where both are required to achieve the intended use, indication, or effect
and where upon approval of the proposed product the labeling of the approved
product would need to be changed, e.g., to reflect a change in intended use
, dosage form, strength, route of administration, or significant change in
dose; or
(4) Any investigational drug, device, or biological product packaged
separately that according to its proposed labeling is for use only with
another individually specified investigational drug, device, or biological
product where both are required to achieve the intended use, indication, or
effect.
s**********8
发帖数: 25265
m*******o
发帖数: 4179
3
比如哮喘病人用的放药的呼吸器?

【在 s**********8 的大作中提到】
: Combination Product Definition
: Combination products are defined in 21 CFR 3.2(e). The term combination
: product includes:
: (1) A product comprised of two or more regulated components, i.e., drug/
: device, biologic/device, drug/biologic, or drug/device/biologic, that are
: physically, chemically, or otherwise combined or mixed and produced as a
: single entity;
: (2) Two or more separate products packaged together in a single package or
: as a unit and comprised of drug and device products, device and biological
: products, or biological and drug products;

s**********8
发帖数: 25265
4
是啊. 好多divice只是一个local的drug delivery system而已.

【在 m*******o 的大作中提到】
: 比如哮喘病人用的放药的呼吸器?
m*******o
发帖数: 4179
5
那种缓释药片算吗

【在 s**********8 的大作中提到】
: 是啊. 好多divice只是一个local的drug delivery system而已.
s**********8
发帖数: 25265
6
你是pharmaceutical product啊, 不是device.

【在 m*******o 的大作中提到】
: 那种缓释药片算吗
m*******o
发帖数: 4179
7
那里面也有drug delivery system啊

【在 s**********8 的大作中提到】
: 你是pharmaceutical product啊, 不是device.
s**********8
发帖数: 25265
8
没device 啊.

【在 m*******o 的大作中提到】
: 那里面也有drug delivery system啊
s**********8
发帖数: 25265
9
你说的那是systematic, 直接进如循环系统.
额说device的delivery, 是local delivery,比如catheter based, 直接放到要去的部
位, 比如肾脏.

【在 m*******o 的大作中提到】
: 那里面也有drug delivery system啊
m*******o
发帖数: 4179
10
明白了,一般都是有硬件的才算device,对吗

【在 s**********8 的大作中提到】
: 你说的那是systematic, 直接进如循环系统.
: 额说device的delivery, 是local delivery,比如catheter based, 直接放到要去的部
: 位, 比如肾脏.

k****i
发帖数: 1126
11
see the definition of medical device by FDA.
As long as one of the following is combined with a drug, it is called
combination.
Medical Device Definition
Medical devices range from simple tongue depressors and bedpans to complex
programmable pacemakers with micro-chip technology and laser surgical
devices. In addition, medical devices include in vitro diagnostic products,
such as general purpose lab equipment, reagents, and test kits, which may
include monoclonal antibody technology. Certain electronic radiation
emitting products3 with medical application and claims meet the definition
of medical device. Examples include diagnostic ultrasound products, x-ray
machines and medical lasers. If a product is labeled, promoted or used in a
manner that meets the following definition in section 201(h) of the Federal
Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug
Administration (FDA)4 as a medical device and is subject to premarketing and
postmarketing regulatory controls. A device is:
"an instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including a component
part, or accessory which is:

recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the
cure, mitigation, treatment, or prevention of disease, in man or other
animals, or
intended to affect the structure or any function of the body of man or other
animals, and which does not achieve any of it's primary intended purposes
through chemical action within or on the body of man or other animals and
which is not dependent upon being metabolized for the achievement of any of
its primary intended purposes."
This definition provides a clear distinction between a medical device and
other FDA regulated products such as drugs. If the primary intended use of
the product is achieved through chemical action or by being metabolized by
the body, the product is usually a drug. Human drugs are regulated by FDA's
Center for Drug Evaluation and Research5 (CDER). Biological products which
include blood and blood products, and blood banking equipment are regulated
by FDA's Center for Biologics Evaluation and Research6 (CBER). FDA's Center
for Veterinary Medicine7 (CVM) regulates products used with animals. If your
product is not a medical device but regulated by another Center in the FDA,
each component of the FDA has an office to assist with questions about the
products they regulate. In cases where it is not clear whether a product is
a medical device there are procedures in place to use DSMICA Staff
Directory8 to assist you in making a determination.

【在 m*******o 的大作中提到】
: 明白了,一般都是有硬件的才算device,对吗
s**********8
发帖数: 25265
12
mark

,

【在 k****i 的大作中提到】
: see the definition of medical device by FDA.
: As long as one of the following is combined with a drug, it is called
: combination.
: Medical Device Definition
: Medical devices range from simple tongue depressors and bedpans to complex
: programmable pacemakers with micro-chip technology and laser surgical
: devices. In addition, medical devices include in vitro diagnostic products,
: such as general purpose lab equipment, reagents, and test kits, which may
: include monoclonal antibody technology. Certain electronic radiation
: emitting products3 with medical application and claims meet the definition

k****i
发帖数: 1126
13
包子真快啊。

【在 s**********8 的大作中提到】
: mark
:
: ,

s**********8
发帖数: 25265
14
额是出了名的快

【在 k****i 的大作中提到】
: 包子真快啊。
1 (共1页)
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