Submit Comments by 02/14/2022

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-D-0997


Docket Number: FDA-2021-D-0997 Issued by:

Guidance Issuing Office

Center for Devices and Radiological Health

Center for Biologics Evaluation and Research

The U.S. Food and Drug Administration (FDA or the Agency) recommends the consistent use of terms and definitions of legal significance. In light of recent amendments to section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as a result of the enactment of the Safeguarding Therapeutics Act, FDA is issuing this draft guidance to promote clarity regarding references to the terms “device” and “counterfeit device.” 

The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.