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Unsurprisingly, the US Food and Drug Administration has missed its fourth consecutive internal deadline for releasing a draft of its retooled Quality System Regulation.

The agency has been harmonizing its decades-old QSR with ISO 13485:2016 for more than two years.

The FDA’s October 2020 target for releasing the draft is the fourth it failed to meet. The agency had previously set deadlines of April 2019September 2019 and April 2020.

Jeff Shuren, director of the agency’s device center, strongly hinted in mid-September that the FDA wouldn’t meet its 31 October deadline. (Also see "Another Delay On The Way? FDA’s Shuren Says Industry Should ‘Anticipate’ QSR Harmonization To Take ‘Little While Longer’" - Medtech Insight, 15 Sep, 2020.)

The revised rule “remains a high priority for the center, but as you can imagine, with all the attention we’ve had … on COVID-19, there are many other activities we could not devote the same level of engagement on. So anticipate that it will be a little while longer before we’re able to issue the ISO 13485 [draft] regulation,” Shuren said at the time.

And complicating the reg rewrite is the FDA’s strained relationship with its overseer, the Department of Health and Human Services. HHS secretary Alex Azar decreed in September that all rules must be signed by him, adding a level of oversight that could lead to further delays for the proposed rule. (Also see "Icy HHS/FDA Relations Could Complicate An Already Drawn-Out Quality System Reg Rewrite" - Medtech Insight, 3 Oct, 2020.)

In fact, Kim Trautman – the lead author of the QSR back in the 1990s – predicts that the FDA won’t release the draft until sometime next year. (Also see "HHS Secretary’s Regs Sign-Off Requirement Will Kick FDA’s Draft QSR Into 2021, Expert Predicts" - Medtech Insight, 23 Sep, 2020.)

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