New Proposed FDA Medical Device Quality System Regulations

Healthcare worker holding marker on MDR graph
Healthcare worker holding marker on MDR graph

New Proposed FDA Medical Device Quality System Regulations and What It Means for You

Earlier this year, the U.S. Food and Drug Administration (FDA), the regulatory body that oversees medical device approvals in the U.S., announced its intention to update current good manufacturing practice (cGMP) requirements of the Quality System Regulation (QSR). The FDA offered the proposal to update U.S. quality systems as written in the Code of Federal Regulations Section 21 Part 820 (21 CFR 820) to line up with those in other countries. The proposed updated medical device quality system regulations will impact medical device companies throughout the country.

Here are some highlights of the proposed changes:

  • Alignment with ISO 13485 The proposal amends the QSR to align with the 2016 edition of ISO 13485 (ISO 13485:2016) to promote consistency, remove repetitive requirements, and assist in getting devices to market. More specifically, it provides:
  • Increased focus on risk management The change puts a greater emphasis on risk management throughout the lifecycle of a product, not just in the validation stage. If the proposed changes take effect, device developers should be prepared to enhance their risk management processes.
  • Updates for Quality Management Systems (QMS) In its proposed medical device quality system regulation updates, the FDA would require a developer to adhere to medical device quality systems using a QMS that adheres to ISO 13485.

Even though the FDA is aiming to follow ISO 13485 more closely, the changes would not include the standard’s “Design and Development” provisions or labeling and packaging requirements.

Additional recordkeeping requirements The FDA’s proposal for medical device quality system regulations seeks to limit gaps in manufacturer records. The administration wants to implement signature and date requirements for records subject to the records control provisions, establish requirements for documenting medical device reporting information in complaints and service records, and require manufacturers to document Unique Device Identification. It also clarifies a manufacturer’s responsibility to make records available.

Replacement of Quality System Inspection Technique (QSIT) The FDA intends to update its QSIT with an approach that matches the updated guidelines, but the proposal does not provide great detail on how it will differ from the current. The proposal does note that it would not be a substitute for the ISO 13485 process nor vice versa, and that training and education will be incorporated into any changes.

Medical device companies are invited to offer comments on the proposed updates through May 24th, 2022.The proposed changes to medical device quality system regulations have been discussed for some time, with the FDA maintaining that the current requirements in 21 CFR 820 are “substantially similar” to ISO 13485:2016 when taken in totality. The FDA anticipates the new rule will take effect one year after final publication. In the world of medical device regulation, it is not a lengthy period, so it’s imperative for companies to start preparing for anticipated changes. Sterling can help. Our FDA medical device regulatory compliance experts can help expand your quality system to ensure regulatory authority scrutiny.


Carrie Britton
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