Search results
Results From The WOW.Com Content Network
Step 1: Determine if your product meets the definition of a medical device per Section 201(h) of the Food, Drug & Cosmetic Act. Step 2: Determine if an appropriate product classification...
Section 201(h) of the Food, Drug & Cosmetic Act (FD&C Act) defines a device as: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other...
FDA’s determination of whether to classify a product as a drug or device is based on statutory definitions, as set forth in sections 201(g) and 201(h) of the FD&C Act, respectively.
For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 820.3 Definitions. (a) Act means the Federal Food, Drug, and Cosmetic Act, as...
Medical Devices. Databases. The information on this page is current as of Mar 22, 2024. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).
(a) Act means the Federal Food, Drug, and Cosmetic Act. (b) Commercial distribution means any distribution of a device intended for human use which is held or offered for sale but does not...
What is an FDA Class III medical device? The FDA defines Class III devices as products which: “usually sustain or support life, are implanted or present a potential unreasonable risk of illness or injury."