Classification of Products as Drugs and Devices and ... | 合法醫療器材資訊網

2018年7月12日—Thefirstclauseofthedevicedefinitionprovidesthattheterm“meansaninstrument,apparatus,implement,machine,contrivance,implant,invitro ...

Docket Number: FDA-2011-D-0429[1] Issued by:

Guidance Issuing Office

Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products

Additional copies are available from:Office of Combination Products Food and Drug Administration WO32, Hub/Mail Room #5129 10903 New Hampshire AvenueSilver Spring, MD 20993(Tel) 301-796-8930(Fax) 301-847-8619Combination Products[2].

For questions regarding this document, contact the Office of Combination Products, at 301-796-8930 or [email protected][3].

Contains Nonbinding Recommendations

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not...

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2019年12月16日 — Per Section 201(h) of the Food, Drug, and Cosmetic Act, a device is: An instrument, apparatus, implement, machine, contrivance, implant, in vitro ... Read More

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2018年9月14日 — an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component ... Read More

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2018年7月12日 — The first clause of the device definition provides that the term “means an instrument, apparatus, implement, machine, contrivance, implant, in vitro ... Read More

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2020年2月7日 — Medical devices are assigned to one of three regulatory classes based on ... A discussion of the meaning of intended use is contained in The ... Read More

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FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. Read More

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2020年9月4日 — Device Advice. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality ... Read More

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2020年10月23日 — Device Advice - Introduction to labeling requirements for medical ... Congress did not, and we cannot, exclude from the definition printed matter ... Read More

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2017年12月19日 — Classification of Medical Devices ... The FDA categorizes medical devices into one of three classes – Class I, II, or III – based on their risks and the ... Read More

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(k) Establish means define, document (in writing or electronically), and implement. (l) Finished device means any device or accessory to any device that is suitable ... Read More

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