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FDA’s Retooled Quality System Regulation Coming ‘Sometime This Year,’ CDRH Chief Shuren Says

Executive Summary

In an exclusive interview with Medtech Insight, FDA device center director Jeff Shuren wouldn’t commit to meeting the agency’s internal deadline of April for putting out a draft version of its revised Quality System Regulation, which will be harmonized with international standard ISO 13485. Instead, he would only say that the rule would likely be out “sometime” in 2020. Shuren added that the FDA wants to “hit the ground running” when the new QSR is eventually finalized.

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Melissa Torres, a US FDA official who is one of many working on the agency’s revision of the Quality System Regulation, offered a few nuggets of news about the process on 8 June. Among them: device makers will have “a few years” to comply with the new QSR; the Quality System Inspection Technique (QSIT) will change; investigators and device center staff will undergo training; and more.

For FDA, The Third Time Wasn’t The Charm For Releasing A Draft Of Its Harmonized Quality System Reg

The US agency missed yet another internal deadline for publishing a draft of its revised Quality System Regulation. The FDA’s April 2020 target for releasing a draft is the third one it failed to meet; it has been working on harmonizing the QSR with ISO 13485 since mid-2018.

Delayed Twice, FDA Now Says It Won’t Release Its Harmonized QSR/ISO 13485 Draft Rule Until April 2020

First it was April 2019, then September 2019 – but both of those deadlines were missed. Now, the US agency has set a target date of April 2020 to release a draft regulation that will harmonize its Quality System Regulation (QSR) with international standard ISO 13485.

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