After Years of Delays, FDA Finally Issues Proposed Rule to Harmonize QSR to ISO 13485

After four long years and constantly slipping timelines, the FDA is finally making good on efforts to harmonize its Quality System Regulation (QSR), defined in 21 CFR 820, with the international standard for medical device quality management systems, ISO 13485, with a proposed rule issued Tuesday, 2/22/2022, with the resulting regulation being dubbed the Quality Management System Regulation (QMSR).

Certification to ISO 13485 is already a requirement for manufacturing and marketing medical devices in many markets, such as Canada which confirms regulatory compliance via the MDSAP (Medical Device Single Audit Program) – which is meant for medical device manufacturers to be able to be audited against medical device QMS requirements for several relevant markets with a single audit – with the US being unique in requiring medical device manufacturers to only meet the QSR requirements, which are very similar in many ways, albeit less prescriptive in how requirements are met. The FDA, in part, made its conclusion for harmonization based on recent experience with ISO 13485:2016 via participation in the MDSAP program.

The FDA first revealed plans for such harmonization in 2018, but the gargantuan task was met with constant upheaval and constant delays, especially in the face of the Coronavirus pandemic. Even still, the agency continued to state that harmonization was one of their top priorities, and with the proposed rule on Tuesday finally revealing their plan for amendment, we can see that they were serious about moving forward.

The current QSR was first issued by the FDA in 1996, the same year that ISO released its first iteration of ISO 13485, establishing the first consensus standard specifically addressing medical device QMS requirements. ISO 13485, however, became widely used throughout the world and continued to evolve into its own stand-alone standard, creating a burden for people marketing devices globally and in the US, as they had to ensure that their quality management systems met the requirements of both ISO 13485 and the QSR.

When the idea was first proposed, the FDA talked about some of the benefits of harmonizing the QSR with the international standard, such as:

  • Opportunities to work more closely with foreigh regulatory authorities
  • A globally harmonized QMS for medical device manufacturers
  • More robust QMS principles
  • Stronger risk management, as defined in ISO 14971

The final register notice released on 2/22/2022 mirrored the initial sentiment with the following statement, “This action, if finalized, will continue our efforts to align our regulatory framework used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.”

The FDA followed, “Over time, ISO 13485 has evolved into a stand-alone standard outlining QMS requirements for devices. With each revision, ISO 13485 has become more closely aligned with, and similar to, the requirements in part 820.”

“[The FDA has] determined that the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the current part 820, providing a similar level of assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective and otherwise in compliance with the FD&C Act.”

The FDA has correctly reasoned that harmonization will reduce the regulatory burden for device makers by eliminating redundancies involved in complying with both the current QSR and ISO 13485. The proposed rule only involves incorporating requirements from ISO 13485:2016, stating, “Any future revisions to this standard would need to be evaluated” before any of its requirements made it into US regulation.

Assessing compliance might change as a result, as well. The FDA has stated that they intend to replace the current approach for assessment, the QSIT (Quality System Inspection Technique), with a new approach consistent with the amended regulation, but that they will still be responsible for inspection and will not be developing an ISO 13485 certification program, “Similar to the QSIT inspection approach, these inspections would involve the collection of information to support observations noted during the inspection and those included on a Form FDA 483, as appropriate and necessary. FDA inspections will not result in the issuance of certificates of conformance to ISO 13485, nor is FDA developing a certification program for ISO 13485. In addition, manufacturers with a certificate of conformance to ISO 13485 are not exempt from FDA inspections.”

The FDA expects the change to result in a cost savings of up to $533 million over 10 years and is proposing to give device manufacturers one year from publication of the final rule to adopt the new requirements.

You can read the Federal Register Notice in its entirety HERE.