Enforcement policy for certain supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions: guidance for industry and Food and Drug Administration staff
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Devices and Radiological Health (U.S.), issuing body.
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, November 2, 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Compassionate Use Trials Device Approval Government Regulation Guideline Adherence United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- The Food and Drug Administration (FDA or the Agency) plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic and other public health emergencies (PHEs). Following approval of a PMA or HDE, an applicant generally must submit a PMA or HDE supplement for review and approval by FDA before making changes affecting the safety and effectiveness of the device unless FDA has advised that an alternative type of submission is permitted for a particular change (e.g., 30-day notice). Following the emergence of COVID-19, FDA first issued this guidance in May 2020 announcing a policy concerning manufacturing processes adjustments to accommodate manufacturing personnel safety relating to the emergency (i.e., social distancing), adaption of manufacturing or design modifications due to supply chain disruptions, and/or moving device production as a result of COVID-19 impacts. In May 2022, FDA updated this guidance to clarify the examples of circumstances, including changes made to microchips or other associated circuitry and/or software changes, where FDA believed a modification would generally not create an undue risk in light of the public health emergency and may be needed to address manufacturing limitations or supply chain issues. At the time, FDA stated that the policy described in this guidance was intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) in accordance with section 319 of the Public Health Service Act (PHS Act). On March 13, 2023, FDA announced in the Federal Register notice “Guidance Documents Related to Coronavirus Disease 2019 (COVID-19),” that this guidance document was being revised to continue in effect for 180 days after the COVID-19 PHE declaration expires, and that, during that time, FDA intends to further revise the guidance. he 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 COVID19 PHE. Since first issuing the Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency guidance in May 2020, FDA’s experience has generally demonstrated that the public health equities weigh in favor of exercising certain enforcement policies for submission of certain PMA and HDE supplements beyond a 180-day extension after the expiration of the COVID-19 PHE (which expired on May 11, 2023). More specifically, FDA has evaluated the benefits and risks to patients and healthcare providers of exercising certain enforcement policies including identifying certain device modifications for which enforcement policies might be appropriate, and assessing other lessons learned from implementation of COVID-19-related enforcement policies for certain device modifications. In addition, notwithstanding the expiration of the public health emergency, FDA has continued to observe supply chain challenges and shortages of medical devices remain widespread. Although this guidance has been revised to remove any expiration date for the enforcement policy, FDA intends to continue to monitor the situation and may make further revisions to the guidance, withdraw the guidance, or pursue other regulatory actions, as appropriate.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (6 pages))
- NLM Unique ID:
- 9918733087206676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918733087206676