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FDA Continues Enforcement Discretion On Some Changes To PMA And HDE Devices

 
• By Elizabeth Orr

The policy allows device developers to change some device materials or manufacturing practices without first alerting the agency, as long as the alterations are a result of manufacturing or supply chain issues.

Scientists working in high-tech facility.
• Source: Shutterstock

The US Food and Drug Administration relaxed notification requirements on some device modifications in May 2020 to ensure a consistent supply of devices during a time of widespread shortages. But two and a half years later, the agency now says this enforcement discretion will continue indefinitely.

That is one of the messages in a 30 October final guidance document, “Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions.”

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