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USFDA Guidance: Supplements for Approved Premarket Approval or Humanitarian Device Exemption

Today (02 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and Radiological Health released the final guidance "Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions".

In the context of medical devices, a Premarket Approval (PMA) is a rigorous FDA process that assesses the safety and effectiveness of certain high-risk medical devices before they can be marketed in the United States.

A Humanitarian Device Exemption (HDE) is a regulatory pathway for certain medical devices intended to benefit patients with rare medical conditions.


To provide a clear policy for all stakeholders and FDA staff, FDA is issuing this guidance to describe FDA's general recommendations for limited modifications to devices that require approval of a PMA or HDE to resolve manufacturing limitations or supply chain disruptions.


This policy applies to limited modifications made to a device approved through the PMA or HDE program that triggers the requirement that a manufacturer submit a PMA or HDE supplement or 30-day notice to FDA.

Example: · Changes in the manufacturing facility or establishment, Changes to packaging procedures


The FDA intends to use this policy to alleviate or mitigate current production limitations, supply chain challenges, or potential shortages that may be alleviated or mitigated by adding production lines or manufacturing at alternative locations.


To understand the requirements and to see more examples click this LINK.


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