Proposed Rule on QSR Harmonization ‘Soon’: Maisel
CDRH is planning to release “very soon” a long-awaited proposed rule to modernize the medical device Quality System Regulation (QSR) by harmonizing and “supplanting” existing requirements with the specifications in the International Organization for Standardization’s (ISO) 13485:2016. Speaking at a virtual Food and Drug Law Institute (FDLI) compliance update 12/9, CDRH Office of Product Evaluation and Quality director William H. Maisel said the proposed rule will help harmonize domestic and international requirements. He said the agency’s approach to harmonizing the QSR will be consistent with and complement the approach of the Medical Device Single Audit Program, adding “we think it will help reduce burden while still giving us a robust quality system across borders.”
The harmonized QSR effort has been in the works for several years, and Covid-19 has delayed its release. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements, the agency has said. The revisions will also modernize the regulation. [Editor’s note: Details on ISO 13485 transition can be found in a white paper discussed here.]
Once the proposed rule is released, it will be several years before it’s fully implemented. Global consulting firm Oriel has said in an earlier post that it is not likely FDA will throw out the QSR entirely. “FDA may incorporate all major components of ISO 13485:2016 into a completely new version of 21 CFR Part 820, with addendums to suit the specific requirements of U.S. law,” the group said. Also, it noted the time needed to implement this massive undertaking. “Hundreds of guidance documents will need to be amended,” it said. “The FDA quality system inspection process (QSIT) will need to be overhauled. A public comment period lasting months or years will have to occur, and the agency will have to conduct an economic impact analysis. And let’s not forget that undoing regulations is often as difficult as implementing them.”
Maisel noted that during the pandemic FDA has increased its reliance on ISO 13485 audits under the Medical Device Single Audit Program (MDSAP), where a third-party auditing organization can satisfy the requirements of multiple regulatory jurisdictions, including the U.S. He said ISO 13485 is used as the standard for the quality program at the manufacturing facilities participating in the audit program. During Covid, he said FDA has been able to “leverage MDSAP audit reports in lieu of FDA surveillance inspections, and there are more than 5,000 participating facilities throughout the world. We leveraged more than 2,000 audits per year over the last two fiscal years.” The MDSAP audits gave the agency a “window into some of the manufacturing facilities and it certainly provided valuable information,” he told the FDLI conference.