Draft Guidance on Referencing the Term "Device"

If your email program has trouble displaying this email, view as a webpage.

FDA - Center for Devices and Radiological Health

Bookmark and Share

FDA Issues Draft Guidance on Referencing the Term "Device"

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Referencing the Term "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents. The FDA invites input from interested stakeholders on this draft guidance.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

Read the Draft Guidance

Note: This guidance is not for implementation at this time.

Submit comments on this draft guidance

This draft guidance will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2021-D-0997.


If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.