The US FDA has gathered members of its Advisory Committee - the Devices Good Manufacturing Practice (DGMP) - for a meeting in early March 2022, to announce the FDA plan and the reasons for it, as well as to obtain public, industry, and Advisory Committee assessment of the plan.
This is part of an ongoing effort to align U.S. quality system requirements more closely with international standards.
The Advisory Committee is chaired by Dr. Yadin David, Interim President of Global Clinical Engineering Alliance and Principal at Biomedical Engineering Consultants. LLC, and in addition to FDA members, includes the following experts:
Yadin David, EdD, PE Biomedical Engineering Consultants, LLC; Houston, TX
Jeri Culbertson, DNP Focus on Zero, LLC; Rapid City, SD
Lisa Dimmick, MS U.S. Nuclear Regulatory Commission; Rockville, MD
Gordon Gillerman, National Institute of Standards and Technology; Gaithersburg, MD
C. Benson Kuo, PhD Dept. of Regulatory & Quality Sciences; Los Angeles, CA
Alisha Loy, LSSBB, CRCST University of Iowa Hospitals and Clinics; Iowa City, IA
Elise Owen, MBA, PMP U.S. Environmental Protection Agency; Washington, DC
Robert Phillips, MBA, RAC Siemens Healthineers; Malvern, PA
Scott Sardeson, RAC 3M Company
According to the FDA, the ISO 13485:2016 standard has:
• Modernized QMS principles
• Greater integration of risk management activities and stronger ties to ISO 14971 than the QS regulation
• Globally harmonized requirements
These features will facilitate reaching the FDA goals of the proposed plan by:
• Simplify and streamline the regulation
• Reduce the burden on manufacturers by aligning FDA’s requirements with globally harmonized QMS requirements
• Incorporate ISO 13485:2016 while keeping country-specific requirements at a minimum
– Only add-in requirements are necessary to remain in alignment with FD&C Act
• Maintain a similar level of assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective
If the plan will be adopted, an overview of the proposal will result in:
• Withdraws most of the requirements in the current part 820
– Retains the scope and several the definitions from the current part 820
• Incorporates by reference ISO 13485:2016
– Minimal called out provisions to ensure consistency with other applicable FDA requirements
• Includes definitions, clarifying concepts, and requirements
• Includes conforming edits to Part 4 (cGMPs for combination products)
– Does not impact the CGMP requirements for combination products
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."
The public comments period is now open, and we encourage you to write the FDA about the proposed plan. https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices.
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