Call Us Today at 508-231-8842                EMERGENCY

In May 2018, the FDA first proposed revising its current Quality System Regulation (QSReg) to better align with ISO 13485:2016. The QSReg is the foundation rule for manufacturing safe and effective medical devices to be sold in the US, while ISO 13485 forms the basis for quality systems compliance with regulators in a variety of countries outside the US.

The problem, however, comes from the fact that the FDA still hasn’t published a draft of its revised QSReg. The FDA has already missed three internal deadlines for releasing it. And more than a month after missing its latest deadline, the agency still hasn’t scheduled a new date for putting out the draft. Melissa Torres, Associate Director for International Affairs in the FDA’s Center for Devices and Radiological Health (CDRH), who has been involved in the QSReg revision process since 2018, has stated that the FDA is “estimating that [they] will issue the proposed rule this year.” The FDA must consider numerous legal requirements while writing the QSReg, and it must undergo a review process. Once the proposed rule is released, the Device GMP Advisory Committee will review the regulations during a meeting. Full details relating to the meeting’s agenda will be released at a future date.

The QSReg was initially published in 1996 and is therefore in need of a revision, but there are many other reasons why updating QSReg regulations to harmonize with ISO 13485 makes sense. The two are already very close in content, with approximately 95% of the requirements the same. The difference is mainly rooted in divergent requirements such as those regarding recordkeeping, design transfer, and labeling, with the FDA being more prescriptive for certain types of requirements. Similarities in terminology have also become more apparent and aligned, and the ISO 13485 is already globally recognized and applied. Torres explains that “it was important to look globally and recognize that ISO 13485 is used by many other regulatory authorities around the world…it was an intention to harmonize with other regulators around the world to have common-core requirements, to reduce burden on industry.” The QSReg revisions will impact US medical device manufacturers in areas like pre- and post-market review programs. And while many FDA inspectors have now been trained to the MDSAP audit, they will need to be trained specifically to ISO 13485. There will likely be a transitional period until the QSReg revisions become wholly acclimated.

If you would like to learn more about the upcoming QSReg revisions or how the harmonization may affect your company, please contact the FDA compliance experts at MEDIcept.

For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.