ARTICLE SUMMARY:
FDA has submitted a proposed rule on QSR/ISO 13485 harmonization. Excerpted from Pathways' Picks January 12.
FDA’s multiyear effort to produce regulations that will better align the US Quality System Regulation with the global ISO 13485 standard finally took a tangible step forward—FDA sent a proposed rule to the White House Office of Management and Budget for review on January 5, meaning the agency has finished writing the document. Harmonizing QSR with ISO 13485 is a complicated endeavor that has many implications for companies’ compliance with design and manufacturing standards. The effort could help reduce duplicative efforts by manufacturers in undergoing audits to satisfy both US and global compliance expectations. FDA has been working on the rulemaking since at least 2018, but has been held up by COVID-19 demands and other factors. The proposed rule can’t be released until OMB’s Office of Information and Regulatory Affairs completes its review, which can take from weeks to months, and more likely the latter for a document of this complexity.
The ISO 13485 quality management systems standard was one of nine standards newly referenced to the Medical Device Regulation and one of five newly linked to the IVD Regulation by the European Commission over the past week. ISO 13485 is one of the most frequently relied-on standards by the global device industry. Now that it has been officially referenced to the new regulations in the Official Journal of the EU (OJEU), companies can leverage the standard to claim a “presumption of conformity” to relevant quality provisions in the MDR and IVDR, saving time and resources. Other broadly-cited device standards addressing issues including biocompatibility, sterilization, use of symbols, and other device processing and quality control methods were also included in the recent OJEU references. A total of 14 standards have now been referenced to the MDR and nine have been referenced to the IVDR. There are still hundreds more to go to have a full sweep of standards available for manufacturers to rely on, including the very significant ISO 14971 risk management standard, which is expected to be included in the next round of references, likely to go to the OJEU in the spring.
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Photo credit: License: Creative Commons 3 - CC BY-SA 3.0; Alpha Stock Images - http://alphastockimages.com/; Original Author: Nick Youngson - link to - http://www.nyphotographic.com/