2023-24213: Enforcement Policy for Certain Supplements for Approved Premarket Approval or Humanitarian Device Exemption Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled "Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions." This guidance outlines FDA's policies and regulatory review expectations after the COVID-19 public health emergency (PHE) for certain limited modifications affecting the safety and effectiveness of a device required to have an approved PMA or the safety and probable benefit of a device required to have an approved HDE. This guidance has been implemented without prior comment, but it remains subject to comment in accordance with the Agency's good guidance practices.
The agency’s own summary, as published.
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