May 27, 2020

The US Food and Drug Administration (FDA) published a noteworthy new guidance document this month, “Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus 2019 (COVID-19) Public Health Emergency.” This reveals a temporary loosening of rules intended to assist medical device and IVD manufacturers confronting problems related to the COVID-19 pandemic, such as social distancing protocols in the workplace, supply chain disruptions, and decisions to move operations to regions with less exposure to the disease.

Limited modifications to device design and manufacture will not jeopardize market access

The FDA in this document addresses medical devices that have received approval via either the premarket approval (PMA) or Humanitarian Device Exemption (HDE) pathways. Minor changes to the design or manufacturing of such devices meant to address challenges resulting from the COVID-19 pandemic will be accepted without requiring further regulatory intervention. Under normal circumstances such changes can only be made via prior submission of a PMA or HDE supplement or 30-day notice to the FDA. The new policy is to apply only for the duration of the current public health crisis.

Included in the guidance is a non-comprehensive list of examples of the types of changes covered:

  • Changes to design and manufacturing addressing the unavailability of certain components resulting from supply chain disruptions
  • Adjustments to the manufacturing process meant to facilitate continued operations while observing social distancing protocols
  • Location changes to different manufacturing facilities
  • Updated packaging procedures

This policy only covers changes based on limitations imposed by current pandemic conditions, and it does not apply retroactively to proposed changes in regulatory submissions already made to the FDA. Manufacturers are expected to document all device changes in their device master records and change control records, making this information accessible to the FDA if requested.

Normal comment period waived due to emergency conditions

This guidance document was published in final form without a prior period of public comment, in line with a Notice in the Federal Register outlining the new process for issuing guidance during the COVID-19 emergency. While the policy contained therein is effective immediately, the agency is soliciting comments from the public on an ongoing basis.

Related US FDA medical device and IVD regulatory resources:

Author

  • Timothy Herr

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