New FDA Draft Guidance Clarifies the Terms Device vs. Counterfeit Device

It is apparent that there has been some problem with the FDA addressing devices as misbranded and/or adulterated when there was not a definition of a “counterfeit” device. So the FDA had to come up with a definition of a counterfeit device and is planning to add it to the definitions under 21CFR201(h). It is interesting that FDA has decided to address this 40 years after the Agency was given regulatory control over medical devices while counterfeit devices have always been around.

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Referencing the Term “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents. The FDA invites input from interested stakeholders on this draft guidance.

With the enactment of the Safeguarding Therapeutics Act (P.L. 116-304) in January 2021, Congress redesignated the definition of “device” and added a new definition of “counterfeit device” within section 201(h) of the Federal Food, Drug and Cosmetic (FD&C) Act. This guidance is intended to provide clarity on references to the terms “device” and “counterfeit device” (as well as existing references to section 201(h) of the FD&C Act) in guidance, regulatory documents, communications, and other documents for the FDA’s staff, industry, and other stakeholders.

Note: This guidance is not for implementation at this time.

Submit comments on this draft guidance

This draft guidance will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2021-D-0997.

Questions?

If you have questions about this draft guidance, contact mdi at info@mdiconsultants.com and reference Device vs. Counterfeit Device.