FDA extends regulatory flexibilities for PMA, HDE modifications

The US Food and Drug Administration (FDA) has published a final guidance that extends its pandemic-era policy of allowing manufacturers to make certain modifications to products that are on the market under a premarket approval (PMA) or humanitarian device exemption (HDE). The move is meant to alleviate supply chain disruptions and device shortages.

In May 2020, FDA published guidance that it has since updated several times to ensure medical devices on the market under PMA and HDE are able to be modified quickly and brought to patients without the need to submit a supplementary product application or 30-day notice. While the policy was supposed to end with the expiration of the COVID-19 public health emergency (PHE), the agency said it will continue to allow flexibility due to current concerns about supply chain disruptions.

FDA released a leapfrog guidance on 1 November 2023 without seeking stakeholder comment. The final guidance document extends its regulatory discretion for certain changes to PMA and HDE products.

“The policy set forth in this guidance was initially intended to address certain manufacturing adjustments and adaptations that needed to be made expeditiously to avoid supply chain disruptions and device shortages or to ensure manufacturing personnel safety during the COVID-19 PHE,” FDA wrote. “[N]otwithstanding the expiration of the public health emergency, FDA has continued to observe supply chain challenges and shortages of medical devices remain widespread.”

While the most recent guidance has been revised to take out any expiration date for the enforcement policy, FDA said it will keep assessing the need to address supply chain shortages by allowing more flexibilities and may update the guidance again. The agency is also accepting stakeholder feedback on how to proceed with its policy, despite the fact it is a final guidance.

FDA said certain design and manufacturing changes to address component shortages, manufacturing changes to address social distancing, changes to manufacturing facilities and changes to packaging procedures may qualify for regulatory flexibility under the latest guidance.

“FDA intends this policy to help address current manufacturing limitations, potential shortages or supply chain challenges that may be alleviated or mitigated by adding production lines or manufacturing at alternative sites,” FDA said. “Such sites may have different manufacturing equipment that can increase manufacturing capacity and supply and/or reduce supply chain interruptions and manufacturing bottlenecks.”

On the other hand, FDA said modifications to products that would change the intended use of the device, labeling changes outside the scope of what is in the guidance, changes to the sterility assurance level (SAL) and changes that affect quality control testing are outside the scope of the current policy. The agency also said the guidance is meant to help transition from pandemic operations to normal processes.

“As always, FDA will make case-by-case decisions regarding the enforcement of legal requirements in response to particular circumstances and questions that arise regarding specific changes to a device or device type,” the agency wrote.

Final guidance
Federal Register docket

FDA extends regulatory flexibilities for PMA, HDE modifications

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