The FDA Quality System Regulation (QSR) 21 CFR Part 820 was written in 1997 to harmonize with ISO 13485:1996. The goal was to relieve some of the burden of manufacturers having to meet two different criteria, the FDA’s and ISO 13485.

But by 2003, ISO 13485 had changed so significantly that the FDA QSR was no longer aligned. Now the FDA wants to update the QSR to align it with ISO 13485:2016. But will that solve the problem? Can the FDA and industry use the new QSR in a cooperative way?

Why the FDA needs to cooperate better with industry

A 2008 U.S. Government Accountability Office (GAO) report indicated that foreign manufacturers see an FDA inspector about once every 26 years, unless they make high-risk devices. Overseas high-risk device makers are visited perhaps once every six years. These numbers haven’t significantly changed. A review of foreign inspections saw a bump in 2012, but a small bump—not one that would satisfy the mandate to audit all manufacturers, worldwide, every two years.

The issue is manpower: To say the FDA has “capacity issues” and is unable to meet its congressional mandate to inspect every two years is an enduring and extreme understatement.

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