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FDA Unveils the Final Rule for Medical Device GMP Requirements
(Thursday, February 1, 2024) In a change more than 20 years in the making, the FDA released the final rule for good manufacturing practices (GMP) for medical devices this week. Although most of the changes incorporated into the final quality systems (QS) regulations have been practically implemented through various policies over the last decade, the final rule contains a few pieces that formally align the US regulations with the prevailing international consensus standards for device production. The final rule, now officially dubbed the Quality Management System Regulation (QMSR), should address any lingering confusion about the differences and similarities between US and international medical device manufacturing GMP practices. The QS regulations have remained unchanged since 1996 and relate to all aspects of medical device manufacture from methods used in, and the facilities and controls used for designing, manufacturing, packaging, labeling, storing, installing, and servicing medical devices. Just like the GMP regulations for drugs and biologics, the QS regulations describe the general framework for establishing good quality practices within which the manufacturers can customize practices for specific devices. The international equivalent of the QS regulations is ISO 13845, which has been formally regarded by the FDA as an acceptable system for manufacturing practices compliant with US regulations for more than a decade. Unlike the QS regulations which have not been revised since 1996, ISO 13485 has been revised a few times and the most current iteration of ISO 13845 is from 2016. The FDA has played an active role in international forums to review and update ISO 13485. One striking aspect of the new regulation is its minimal impact on manufacturers currently adhering to the existing QS regulations along with ISO 13845. Since ISO 13845 and QS regulations are very similar anyway, the new rule will not create an additional burden of compliance for manufacturers following the current QS regulations. Perhaps that is why the FDA received very few comments on the proposed rule when it was released about a year ago. Going forward, it would also make it much easier for US manufacturers to get ISO 13845 certification. The final rule is set to take effect on February 2, 2026, giving the manufacturers two years to update their processes to align with the Final Rule. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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