ARTICLE SUMMARY:
FDA issued 31 draft and final guidance documents on January 6, just two weeks before the current HHS/FDA leadership exits and the Trump administration takes power. Several of the documents in particular should be on device companies’ radar: Excerpted from Pathways’ Picks January 8: FDA Guidance Bonanza, Diversity Action Plans, and Global Picks.
FDA published a major draft guidance (public comments due April 7) on “Lifecycle Management and Market Submission Requirements” for AI-enabled devices. It will complement the recently finalized guidance on the use of “predetermined change control plans” for AI/ML devices, providing more comprehensive recommendations on design, development, maintenance and documentation requirements for these software-based products. On the same day, FDA published a separate draft guidance with recommendation on using AI to support drug and biologic development.
The agency published a hotly anticipated draft guidance (comments due March 10) on pulse oximeters, specifically to lay out new recommendations for manufacturers to evaluate their devices across the range of skin pigmentation. The draft comes following years of discussion, including multiple FDA advisory panel meetings about data showing less accurate results for oximeter for patients with darker skin. For pulse oximeters on the market that can meet the updated performance criteria without significant modifications, FDA says it will review updates labeling referencing clinical data across skin pigmentations within 30 days of submission.
FDA issued an updated draft (comments due April 7) of its existing guidance on evaluating sex-specific data (i.e. distinct data based on the biologic construct of male versus female) in device studies to address the distinct issue of gender-specific data. The draft guidance defines sex as a biological construct of male or female, and gender as a multidimensional construct that encompasses how an individual self-identifies, for instance, as a man, woman, nonbinary, or transgender person. The guidance was initially created in part to address historic underrepresentation of females in device studies. The updated draft additionally noted, “Historically, as gender was often conflated with sex or otherwise not properly reported in clinical studies, there is a lack of data regarding the underrepresentation of nonbinary, transgender, fluid gender identities and other gender identities.” On the same day, FDA issued a separate draft guidance addressing the “study of sex differences” in clinical evaluation relevant to all medical products (devices, drugs, and biologics.)
What the agency wants to see from test developers to ensure diagnostics are properly validated for an emerging pathogen during an official emergency declaration is addressed in another January 6 draft guidance (comments due March 7). The guide incorporates lessons learned in particular from the COVID-19 pandemic. It applies to test data/information that could be submitted in a pre-Emergency Use Authorization (EUA), an EUA request, or under an enforcement discretion policy.
FDA finalized an update to its guidance on when and how manufacturers must notify the agency of “permanent discontinuance or interruption in manufacturing of a device,” including an updated list of device product codes that are subject to mandatory notifications under the law. Section 506J of the Food, Drug, and Cosmetic Act mandates companies to make such notifications “during, or in advance of, a public health emergency,” and more recent legislation required FDA to compile a list of specific devices that are subject to the law and also clarify how firms can submit voluntary notifications.
The agency also finalized a guidance detailing how and when companies (device and drug) can go about communicating scientific information to healthcare providers related to unapproved uses of products without getting into compliance trouble. Notably, FDA decided to rush out the final document before the White House Office of Management and Budget completed its ongoing review of the guidance. As a result, even though its final, “this guidance is not for current implementation,” FDA says.
Finally, the agency, led by its Oncology Center for Excellence, issued a draft guidance (comments due March 10) for trial sponsors, as well as investigators, sites, and institutional review boards, on considerations for taking tissue biopsies during clinical trials for investigational medical products.