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QSR/ISO 13485 Harmonization Update: FDA Enforcement Discretion Likely When New Rule Stands Up; Draft Reg Coming By Year's End

 
• By Shawn M. Schmitt

All signs point to the US agency exercising enforcement discretion for device-makers when it rolls out a new final rule that merges the Quality System Regulation with international standard ISO 13485. "We'll give companies time on the transition," FDA device center chief Jeff Shuren said at the MedTech Conference on 25 September. Meanwhile, an industry insider tells Medtech Insight that a draft of the regulation probably won't be out until the end of the year because of "disagreements technically on the inside" of the agency.

CDRH Director Jeff Shuren
FDA device center director Jeff Shuren talks about the QSR/ISO 13485 mash-up at the MedTech Conference on 25 September • Source: Ferdous Al-Faruque

[Editor's note:The original version of this story said the FDA was planning town hall events to educate industry on the draft regulation and to collect feedback from stakeholders. This story was updated on 1 October to reflect that the agency has not yet committed to any particular type of outreach to industry. The agency tells Medtech Insight, however, that it will engage with industry and stakeholders to obtain feedback and answer questions, as appropriate, upon publication of the proposed rule.]

The US Food and Drug Administration will likely exercise enforcement discretion for device-makers when the agency rolls out its new rule that harmonizes the Quality

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