Classify Your Medical Device | 合法醫療器材資訊網

2020年2月7日—Medicaldevicesareassignedtooneofthreeregulatoryclassesbasedon...AdiscussionofthemeaningofintendeduseiscontainedinThe ...

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are:

Device Class and Regulatory Controls

1. Class I General Controls

With Exemptions Without Exemptions

2. Class II General Controls and Special Controls

With Exemptions Without Exemptions

3. Class III General Controls and Premarket Approval

The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA ...

definition of a medical device | 合法醫療器材資訊網

How to Determine if Your Product is a Medical Device | 合法醫療器材資訊網

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

Medical Device Overview | 合法醫療器材資訊網

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

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

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

Classify Your Medical Device | 合法醫療器材資訊網

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

Medical Devices | 合法醫療器材資訊網

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

Overview of Device Regulation | 合法醫療器材資訊網

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

Medical Device Labeling | 合法醫療器材資訊網

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

Overview of Medical Device Classification and ... | 合法醫療器材資訊網

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

CFR | 合法醫療器材資訊網

(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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