The FDA plans to publish a proposed rule in Q1 2019 to align 21 CFR 820 Quality System Regulation, which details medical device quality system regulations, and ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes.
On May 9, 2018, the FDA made an official statement that this rule, if finalized, will harmonize domestic and international requirements and modernize the regulation to make it more efficient for manufacturers of medical devices seeking to sell their products globally, while also continuing to ensure they adhere to high, internationally-accepted quality systems.
One item of note would be the ISO standard's copyrighting. Every US regulation which is issued in the Federal Register needs to be available to the public free of charge. 13485 is an ISO standard and is copyrighted. It may be more efficient for the FDA to revise the QSR and align it with ISO 13485, rather than replacing the regulation with the standard.
***USDM will update this blog until the revision is finalized noting progress as it occurs. Please stay tuned to this blog for further information.***
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About the Author
Armand Mintanciyan is an Engagement Lead at USDM Life Sciences. Armand is overseeing the maturity of the Oracle/ERP Commercial Cloud Assurance solutions and is working very closely with both clients and partners helping navigate the regulatory landscape, and providing guidance and alignment. Armand has over 25 years experience in compliance, quality, and validation for pharmaceutical, bio-tech, and medical device companies in enterprise IT (discovery, clinical, manufacturing). He has worked on projects assuring compliance with Data Integrity, GAMP 5, 21 CFR Part 11, and EudraLex Volume 4 Annex 11. His experiences include ERP, IT Infrastructure, QMS, EDMS, LIMS, Chromatography, Data Integrity, and Cloud based systems and has worked on and led multiple FDA Consent Decree Remediations (including methodology implementation).
About USDM Life Sciences
USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world, and boast a staff of industry leading experts in the areas of technology and compliance.