Findings
The QS regulation under 21 CFR Part 820 has been effective but requires updates to align with global standards like ISO 13485.
Adopting ISO 13485 will harmonize FDA requirements with international practices, benefiting manufacturers that sell devices globally.
FDA’s proposed amendments retain some unique provisions to ensure alignment with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The incorporation of risk management principles throughout the product lifecycle is more explicit in ISO 13485 than in the current QS regulation.
The proposed changes are expected to reduce regulatory burdens and enhance device quality and accessibility.

Recommendations
Align quality management systems with ISO 13485 to ensure compliance with both U.S. and international regulatory requirements.
Establish documentation processes that meet FDA’s additional requirements, such as those for traceability and complaint handling.
Incorporate risk management throughout the device lifecycle, as emphasized in ISO 13485.
Manufacturers should train personnel and update their systems to comply with the new requirements within the proposed one-year transition period.
Provide comments on the proposed rule to FDA before the deadline to address any potential concerns or suggestions for improvement.

Regulatory Considerations
The proposed rule incorporates ISO 13485:2016 by reference and aligns FDA’s QS regulation with international QMS standards.
FDA-specific requirements include:
Traceability for certain life-supporting devices.
Documentation of unique device identifiers (UDI) in compliance with FDA’s regulations.
Complaint handling and servicing records that meet FDA standards.
FDA inspections will not issue ISO 13485 certifications but will assess compliance with the proposed Quality Management System Regulation (QMSR).
Manufacturers must continue to comply with existing FDA regulations where conflicts with ISO 13485 arise.