GLBT AMERICA Manufacturing FDA calls device manufacturing expert meeting to discuss quality system harmonization

FDA calls device manufacturing expert meeting to discuss quality system harmonization

Table of Contents

Dive Brief:

  • FDA has convened its Device Good Manufacturing Practice Advisory Committee for the first time in almost a decade to discuss plans to harmonize its Quality System Regulation.
  • The long-gestating plan to bring U.S. quality system requirements in line with international consensus standards has advanced this year, with FDA’s proposed rule undergoing a successful review by the U.S. Office of Information and Regulatory Affairs (OIRA), which is part of the White House’s Office of Management and Budget.
  • FDA’s scheduling of the advisory committee for March 2 and commitment to share background materials at least two business days before the meeting suggests the public may get to see the proposed rule this month. FDA is accepting written submissions until Feb. 24.

Dive Insight:

FDA is gathering advisory committee experts to “discuss and make recommendations on the current good manufacturing practice requirements for medical devices,” as part of an ongoing effort to align U.S. quality system requirements more closely with international standards.

That summary of the agenda suggests the meeting will focus on the proposed rule that FDA submitted for review by OIRA at the start of the year. OIRA completed the review earlier this month, well ahead of schedule, and FDA has maintained the pace by quickly convening an advisory committee meeting.

The pace of progress contrasts sharply with the previously limited evidence of forward momentum. FDA began work on a plan to harmonize its rules on quality management systems with the internationally adopted standards, called ISO 13485:2016, in 2018 in the belief global alignment will reduce manufacturer burdens. The proposed rule was scheduled for release in 2019 but is yet to be published. 

FDA is now gathering experts to get feedback on its plan. The advisory committee is chaired by Yadin David, principal at Biomedical Engineering Consultants, and, in line with its charter, has two members who represent the interests of the device manufacturing industry. Siemens Healthineers’ Robert Phillips and 3M Health Care Business’ Scott Sardeson are on the roster

None of the experts who attended the previous 2013 meeting are on the current roster. Back then, FDA gathered experts to discuss the “potential effects of extreme weather events and natural disasters on medical device manufacturing chain processes and marketed medical device safety and quality.” The meeting grew out of talks triggered by Hurricane Katrina and Hurricane Sandy.

While FDA lists the most recent meeting as 2013, work related to the committee has happened in recent years. In 2020 and 2021, work focused on “reviewing applications for new nominees, maintaining associated records for these activities, and streamlining paper processes within FDA.”