FDA Regulatory News and Trends - March 4, 2024

Welcome to FDA Regulatory News and Trends, designed to help you identify significant legal developments and navigate the evolving business, legal, and regulatory world.

FDA guidance aimed at preventing drug shortages.

• In February 2024, FDA finalized guidance on annual reporting of listed drugs and biological products for manufacturers subject to Coronavirus Aid, Relief, and Economic Security Act (CARES Act) reporting requirements.


• The guidance clarifies which establishments are subject to reporting requirements – “registrants” are those involved in the manufacture, preparation, propagation, compounding, and/or processing of a drug for commercial distribution – and describes the information required for submission.


• While the final guidance has responded to many concerns raised in response to the draft guidance, the reporting deadline has not been relaxed. Registrants have until August 26, 2024 to submit their reports for calendar year 2023. After that, registrants will be required to submit annual reports no later than March 31 for the previous calendar year.


• Additionally, FDA published new draft guidance on notifying FDA about changes in the production of certain finished drugs, biological products, and active pharmaceutical ingredients. The draft guidance recommends providing details related to discontinuance or interruption of manufacturing to ensure FDA has the specific information it needs to help prevent or mitigate shortages. Any comments should be submitted to the docket by April 5, 2024.

Significant update to FDA device manufacturing regulations.

• On January 21, 2024, FDA issued a final rule amending its medical device Quality System (QS) regulations under 21 CFR Part 820 to more closely harmonize with the international consensus standard ISO 13485:2016. This revised set of FDA regulations is now referred to as the Quality Management System Regulation (QMSR).


• While principles described in the new QMSR largely align with prior requirements under the QS regulations, a few differences are worth noting. For example, the principles place a greater emphasis on risk-based decision making and amend certain key terminology. Further, according to the regulations, management reviews, quality audits, and supplier audits are no longer shielded from FDA review.


• FDA is giving manufacturers two years to adapt to the new set of regulations, with an enforcement date of February 2, 2026. The medical device industry is encouraged to review its systems for necessary changes and begin planning for implementation ahead of time. Our recent alert provides further information on the QMSR and identifies key takeaways for companies in the US, the EU, and China.

CDRH intends to down-classify most in vitro diagnostics.

• On January 31, 2024, the FDA Center for Devices and Radiological Health (CDRH) announced its intent to reclassify most in vitro diagnostics (IVDs) from class III (high risk) to class II (moderate risk). Reclassification would allow manufacturers to seek marketing clearance through the less burdensome premarket notification (510(k)) pathway rather than through the premarket approval (PMA) pathway.


• The center explained that the majority of tests to be reclassified are infectious disease and companion diagnostic IVDs, and that reclassification would encourage more manufacturers to develop these tests, thus increasing competition and access. Similar reclassifications occurred in September 2023 with tests for detecting hepatitis B, human parvovirus B19, and tuberculosis.


• IVD manufacturers are encouraged to monitor CDRH's progress related to the reclassification process and familiarize themselves with the 510(k) requirements now in preparation for potential reclassification.

Draft guidance on the use of data monitoring committees in clinical trials.

• On February 13, 2024, FDA published a draft guidance entitled, “Use of Data Monitoring Committees in Clinical Trials.”


• The guidance is intended to assist sponsors of clinical trials in determining whether a data monitoring committee (otherwise known as a data and safety monitoring board, a data and safety monitoring committee, or an independent data monitoring committee) would be useful for trial monitoring. The guidance also outlines which procedures and practices should be considered to guide operations when evaluating certain investigational drugs, biological products, and devices that require such monitoring.


• Interested parties should submit their comments on or before March 13, 2024. When finalized, this guidance will supersede the 2006 final guidance for clinical trial sponsors entitled, “Establishment and Operation of Clinical Trial Data Monitoring Committees.”

Draft guidance on testing for fish and fishery products subject to detention.

• On February 5, 2024, FDA’s Center for Food Safety and Applied Nutrition (CFSAN) published a draft guidance, entitled, “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE.”


• This guidance provides recommendations and clarifications for collecting samples for testing when fish and fishery products are subject to detention without physical examination (DWPE) due to the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition. FDA also sets out recommendations for foreign manufacturers and processors submitting testing evidence to support requests to remove products from DWPE when subject to DWPE under an import alert.


• Interested parties should submit their comments on or before April 12, 2024.

CVM guidances on adverse event reports.

• On January 31, 2024, FDA’s Center for Veterinary Medicine (CVM) issued two final guidance documents, “CVM GFI #188 Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine“ and “CVM GFI #214 (VICH GL35) Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of Data.” Both guidances focus on Adverse Event Reports (AER) for veterinary medicinal products.


• CVM GFI #188 provides detailed instructions on how to fill out Form FDA 1932, “Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report.” This is a mandatory report under 21 CFR 514.80 where a Marketing Authorization Holder (MAH) must report adverse drug experiences (ADEs) and product/manufacturing defects on Form FDA 1932. Firms named on the label as a manufacturer, packer, or distributor may also use this form.


• CVM GFI #241 provides recommended electronic standards for transfer of data to construct a single AER electronic message to all member regions, and on submitting Product Problem Reports (PPR) to FDA for veterinary medicinal products.