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—PerSection201(h)oftheFood,Drug,andCosmeticAct,adeviceis:Aninstrument,apparatus,implement,machine,contrivance,implant,invitro ...

On this page: Introduction

Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems. Additionally, medical devices include in vitro diagnostic[1] (IVD) products, such as reagents, test kits, and blood glucose meters. Certain radiation-emitting electronic products[2] that have a medical use or make medical claims are also considered medical devices. Examples of these include diagnostic ultrasound products, x-ray machines and medical lasers.

Device Determination Steps

The following steps may be helpful when trying to determine if a product is regulated by the FDA as a medical device.

Step 1:[3] Determine if your product meets the definition of a medical device per Section 201(h) of the Food, Drug & Cosmetic Act. Step 2:[...

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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