RA/QA News Roll: Late September 2024

Here's what's happening at FDA and across the broader life science RA/QA space.

This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.

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Here are some key items from the past couple of weeks.

💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.

FDA Guidances, Regulations, and Related Documents

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• The FDA has released a major new draft guidance document outlining recommended methodological approaches for chemical analysis in biocompatibility assessments of medical devices. This 45-page guidance details specific tests that companies should consider using while also noting that other options may be appropriate. 💉

• The CDRH has published a trio of long-awaited guidance documents regarding its Accreditation Scheme for Conformity Assessment (ASCA) Program. This program is designed to enable qualified accreditation bodies to accredit testing laboratories to conduct premarket testing for medical device companies. The three guidances released by the FDA pertain to the program itself, biocompatibility testing of devices under the program, and the basic safety and essential performance criteria for devices. 💉

• The FDA has released a batch of new final guidance documents pertaining to the CDRH Safety and Performance Based Pathway, which was launched in September 2019. This pathway allows sponsors to demonstrate compliance with FDA-identified standards for product clearance instead of relying on comparative testing with a predicate device. The latest guidance documents address performance criteria for dental impression materials, dental ceramics, dental cements, and air-powered dental handpieces and air motors. These guidances are effective immediately and do not require prior public comment. 💉

• The FDA has released a revised version of the CDER Manual of Policies and Procedures (MAPP), which focuses on communicating target dates related to labeling, anticipated Postmarketing Requirements (PMRs), and 506B Postmarketing Commitments (PMCs) to applicants of New Drug Applications and Biologics License Applications. The document was updated to "align with current OND [Office of New Drugs] organizational structure, applicable UFA [User Fee Act] commitments, and contemporary CDER workflow procedures and best practices," according to the FDA. 💊

FDA General

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• The FDA has announced the completion of a 64,000-square-foot expansion and renovation of its National Forensic Chemistry Center (NFCC) in Cincinnati. The NFCC serves as the FDA’s national forensic laboratory, providing specialized laboratory services in analytical chemistry and molecular/microbiology related to adulteration, contamination, counterfeiting, and product tampering of FDA-regulated commodities, including drugs, dietary supplements, foods, cosmetics, veterinary feeds, and medical devices. 💊 💉

• On September 18, during a RAPS Convergence session on implementing the FDA's proposed rule for Nonprescription Drug Products with an Additional Condition for Nonprescription Use (ACNU), Danielle Terrell from the FDA stated that the agency expects to issue the final rule by October 2024. This timeline aligns with the FDA's Spring 2024 Unified Agenda target. 💊