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

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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