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FDA is finalizing amendments to its "intended use” regulations for medical products ( 201.128 and 804.1).  This action amends FDA’s regulations describing the types of evidence that are relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA’s implementing regulations.   

The Agency issued a proposed rule in 2015 and a final rule in 2017 revising the language of its medical product intended use regulations, with the intent to conform them to the Agency’s current practice in applying the regulations. Comments raised legal concerns with the January 2017, final rule. Although the 2015 proposed rule had received favorable reactions, commenters on the January 2017, final rule criticized changes that were made in the process of finalizing the rule. After receiving a petition that requested the Agency reconsider these amendments, FDA delayed the effective date of the 2017 final rule and reopened the docket to invite public comment. On March 18, 2018, FDA delayed the effective date of the intended use amendments until further notice to allow further consideration of the substantive issues raised in the comments received. 

After considering these issues, FDA issued a proposed rule in September 2020, to repeal the portions of the January 2017, final rule that never became effective, and proposed a new rule to clarify the types of evidence that are relevant in determining a product’s intended uses, thereby supporting FDA’s ability to regulate medical products, including drugs and devices.  This action finalizes the amendments to the intended use regulations.