The new rule on intended use has been updated by the US Food and Drug Administration (FDA) and would repeal and replace previous portions of the earlier final rule. The updated rule (21 CFR 201.128 and 801.4) was published during September 2020. The delays in publication were due to the concern and misunderstandings raised by groups from the pharmaceutical and biotech industry. The new ruling states whether a product meets the classification of a drug or device. Also, the new ruling clarifies that industry’s knowledge of “off-label” use would not trigger new requirements on the manufacturer’s behalf such as, labeling, marketing materials, and operating procedures.
Instead of changing FDA’s policies and practices, the agency clarified the regulatory language to describe the kind of evidence considered appropriate to defining a product’s intended use(s).¹ Evidence of intended use may consist of, but is not restricted to, the product’s labeling claims, promotional material, oral or written statements, and advertising. An individual corporation might have to review their marketing, product development, and communication strategies with this new ruling.²
The quality and regulatory advisors at Pearl Pathways stay up-to-date on all of FDA’s new guidances and regulations to help our clients plan accordingly for changes in the industry. If you have questions about how FDA’s updated intended use definition applies to your product, contact us today to schedule a free 30-minute consultation.
²https://www.federalregister.gov/documents/2020/09/23/2020-20437/regulations-regarding-intended-uses