Devices

More Device Inspections Yields Better Compliance: CDRH

David McFarland

— 1 min read
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CDRH has released a Medical Device Enforcement and Quality Report it says demonstrates that increased inspections of medical device manufacturers and a targeted risk-based approach leads to improved compliance. “As medical device manufacturing has become an increasingly global enterprise,” says CDRH director Jeffrey Shuren, “FDA has taken forceful action to increase inspections of medical device firms, especially those located in foreign countries. Over the past decade we’ve increased the annual number of international device inspections by 243% taking into account that Quality System issues are more likely to occur in firms located overseas. Our increased oversight has led to tangible results with improved compliance. The report finds that: 

  •          FDA has increased its oversight through additional device inspections;
  •          FDA has taken a targeted, risk-based approach to address specific device areas of concern;
  •          FDA’s focus on violative products and adverse event reporting during inspections has led to an increase in voluntary recalls and adverse event reporting;
  •          most firms have corrected violations on follow-up inspection; and
  •          FDA has taken steps to promote device quality and not just compliance with regulations.

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