FDA Finalizes PCCP Guidance for AI-Enabled Medical Devices

In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high interest to patients, clinical communities, industry stakeholders and policy-makers in Congress.

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers.” The guidance outlines FDA’s enforcement policy concerning certain firm-initiated communications of scientific information on unapproved uses (SIUU) of the firm’s approved or cleared medical products to health care providers involved in prescribing or administering those products to individual patients. It finalizes the October 2023 draft guidance, which itself revised draft guidance from 2014 and 2009. The latest guidance is not for current implementation and is pending the Office of Management and Budget’s (OMB) approval of the guidance’s information collection provisions.

On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022 petition filed by the Center for Science in the Public Interest, among other food safety and health advocates, which asserted that the additive induces cancer in male rats and urged the agency to revoke authorization. 

On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance of body weight in patients with obesity or who are overweight. Notably, this draft guidance includes recommendations with respect to the clinical assessment of weight reduction drugs in both adults and pediatric patients, revising and replacing the draft guidance for industry “Developing Products for Weight Management” issued in February 2007. 

On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway. Under the Consolidated Appropriations Act, 2023, Congress gave the FDA the authority to require that a confirmatory trial be underway prior to the granting of accelerated approval or within a specific time period after the date of accelerated approval. This latest guidance comes on the heels of the accelerated approval guidance issued by the agency just last month (see prior analysis here), in which the agency stated its intent to address the 2023 authority in a separate guidance.

On January 6 and 7, 2025, the FDA announced, by our count, 31 draft or final guidances, on a wide range of topics. Historically, an incoming administration will impose a temporary freeze on the issuance of guidances and rules, and might ultimately have different policy priorities and goals than the previous administration. Thus, the release of these numerous new guidances reflects topics that the FDA likely views as particularly important to address.

On December 30, 2024, FDA unveiled an Idea Lab as part of its Home as a Health Care Hub initiative to reimagine how new and existing medical devices can be incorporated in a home environment.

On December 12, 2024, FDA’s Center for Drug Evaluation and Research (CDER) announced a new CDER Center for Real-World Evidence Innovation (CCRI). The CCRI is intended to serve as the focal point to promote more efficient and consistent communications across CDER offices regarding real-world data (RWD) and real-world evidence (RWE).