 
Today, the U.S. Food and Drug Administration (FDA) issued a guidance, which takes effect immediately, titled: Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions.
The guidance provides recommendations for limited modifications affecting the safety or effectiveness of a device approved through the FDA’s PMA or HDE program, where the modification is necessary to address current manufacturing limitations, potential shortages, or supply chain issues.
Examples of such modifications may include, but are not limited to:
- Design and manufacturing changes to address component unavailability due to supply chain disruptions
- Manufacturing changes to allow the establishment to maintain operations and accommodate social distancing in appropriate situations based on local conditions
- Changes in manufacturing facility or establishment
- Changes to packaging procedures
In lieu of prior submission of a required PMA or HDE supplement or 30-day notice, the FDA does not intend to object to these limited modifications within the scope of the guidance being implemented with a retrospective update in the next periodic report.
This guidance supersedes the guidance titled Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, issued in May 2020 and updated in May 2022.
This guidance document is being implemented immediately. Stakeholders can still submit comments on this guidance in accordance with the FDA’s good guidance practices to https://www.regulations.gov as described in the guidance.
Questions?
If you have questions about this guidance, contact the Division of Industry and Consumer Education.
|
