CDRH Eyes Quality, Program Alignment for 2018 Inspections

November 6, 2017

Moving into 2018, CDRH is focused on two main objectives to change how inspections of medical device manufacturing facilities are conducted — the case for quality and program alignment.

As the healthcare system shifts its focus toward the quality of services provided, so will the strategy for inspecting and surveilling medical device manufacturers, Captain Sean Boyd, acting director at CDRH’s Office of Compliance, said at the 12th Annual FDA Inspection Summit hosted by FDAnews.

Shifting the focus toward quality will help CDRH understand patient needs and expectations to incorporate them into regulatory decision-making, Boyd said.

Compliance will still be important, but there will be an increased focus on quality because a manufacturer that has demonstrated compliance with FDA requirements may not necessarily be providing quality devices, he said.

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