Breaking medical device news: FDA sent its Quality Management System Regulation (QMSR) 

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After years of waiting, the FDA has finally sent its QMSR final rule to the White House for review and clearance

The latest deadline set by the FDA to publish the QMSR final rule is by the end of December 2023. However, it’s possible that this deadline may still be missed as the review process by OIRA typically takes several weeks, depending on the complexity of the rule and the extent of industry feedback. Regardless, the industry should expect the QMSR final rule to be released either in late December or early Q1 2024.

As stated in the final rule’s abstract, the revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016.

Since early 2018, the FDA has been working to align its QSR with the worldwide quality systems standard ISO 13485. The FDA has included the QSR revamp as one of its anticipated regulatory initiatives in each of its biannual unified agendas since this time.

Part of the FDA’s reasoning for harmonizing its regulations with ISO 13485 is reducing the regulatory burden for device makers by eliminating redundancies involved in complying with both the ISO and QSR standards.

Here are some of the suggested strategic steps for readiness:

  1. Adopt ISO 13485:2016 standards.
  2. Consider MDSAP certification
  3. Guard against complacency
  4. Develop a cross-reference/matrix document
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