FDA Issues Long-Awaited Quality System Regulation Amendments

February 24, 2022

After four long years and a series of delays, the US Food and Drug Administration released its proposed rule for amending the Quality System Regulation to be harmonized with ISO 13485:2016. In a somewhat surprising move, the proposed rule eliminates the substance of the Quality System Regulation and incorporates ISO 13485:2016 by “reference.” As a result, the proposed rule retitles 21 C.F.R. Part 820 to “Quality Management System Regulation.”


Below are some key takeaways of the US Food and Drug Administration’s (FDA) proposed rule:

  • To harmonize the proposed rule with requirements of the Federal Food Drug and Cosmetic Act (FFDCA), the proposed rule retains many of the definitions from 21 C.F.R. § 820.3. Where definitions from the proposed rule and ISO 13485:2016 conflict, the proposed rule explains that the regulation’s definitions will take precedence.
  • The proposed rule retains provisions from the current Quality System Regulation (QSR) not included within ISO 13485:2016. For example, the proposed rule retains:
    • the exclusion of design controls to most Class I devices;
    • specific complaint handling requirements for events that are reported to FDA as Medical Device Reports (MDRs) per 21 C.F.R. Part 803; and
    • device labeling and packaging control requirements.
  • FDA commentary to the proposed rule provides a trace table which compares the subsystem of the QSR to the subsystems of ISO 13485:2016 and concludes that the requirements are “substantively similar.”
  • The proposed rule explains that it will be effective one year after finalization.
  • FDA commentary to the proposed rule makes clear that it will not accept ISO 13485:2016 certifications by third parties as a replacement for routine FDA inspections —firms will need to participate in the Medical Device Single Audit Program (MDSAP) to avoid routine FDA inspections.
  • FDA commentary to the proposed rule explains that it will be replacing its Quality System Inspections Technique (QSIT) with a new guide for performing FDA inspections.
  • The proposed rule will still only apply to finished device manufacturers, although FDA reiterates in its commentary that it has the ability to apply the requirements to suppliers of components and materials to finished device manufacturers.
  • The proposed rule makes conforming changes to the device manufacturing aspects of the combination product regulation, 21 C.F.R. Part 4.

Comments on the proposed rule are due by May 24. Additionally, FDA will host a public Device Good Manufacturing Practice Advisory Committee meeting on March 2, during which the proposed rule will likely be discussed.


Although it was expected for the QSR to be amended to be consistent with ISO 13485:2016, it was unexpected for the entire substance of the QSR to be gutted with a “reference” to the international standard. However, by incorporating ISO 13485:2016 by reference, there will be no question that adherence to the international standard will conform with FDA requirements (something that the industry has been asking FDA for years). Although FDA explains that the incorporation is specific to ISO 13485:2016, using the “reference” mechanism may make it easier for FDA to codify future revisions of ISO 13485 (which changed more frequently than the legacy QSR, which has been static for almost the last 20 years).

Although the current QSR and ISO 13485:2016 are substantively similar, there are explicit differences of which regulated firms should be aware. For example, ISO 13485:2016 requirements explicitly place greater emphasis on using risk management to drive quality system decisions (a key change from ISO 13485:2013). Specifically, with respect to supplier management, the requisite level of supplier qualification and control is to be directly related to the risk associated with the components and materials the supplier is providing to the manufacturer. In addition, ISO 13485:2016 includes more specific requirements that govern the relationship between the manufacturer and the supplier. Past experience has shown that FDA was generally interpreting the QSR to be consistent with ISO 13485:2016 so these changes should not be entirely disruptive to industry.


Morgan Lewis will be hosting a webinar on March 16 at 12:00 pm EST/9:00 am PST to discuss the proposed rule and what it may mean for regulated firms.


Morgan Lewis guides and provides strategic counseling to finished medical device manufacturers and suppliers on the establishment of quality systems that comply with the FFDCA. Morgan Lewis routinely drafts quality system policies, procedures, and systems. Certain Morgan Lewis’s lawyers have been certified and trained on ISO 13485:2016 as well as FDA’s Medical Device Single Audit Program by international certification organizations.

Morgan Lewis’s knowledge on the regulation stems from defending regulated firms in FDA inspections, as well as developing corrective action plans in response to FDA inspectional observations and enforcement actions.


If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:

Washington, DC
Dennis C. Gucciardo
Michele L. Buenafe
Maria Kalousi-Tatum