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While you can comment on any guideline at any time (see 21 CFR 10.115 (g) (5)), to ensure that the FDA considers your comment on a draft guideline before starting work on the final version of the guideline. guideline, submit either online or written comments on the draft guidance before the closing date.
If you are unable to submit comments online, please send your written comments to:
Food and drug administration
5630 Fishers Lane, Rm 1061
Rockville, Maryland 20852
All written comments should be identified with this document’s file number: FDA-2022-D-0053
- File number:
- Issued by:
Guidance issuance office
Center for devices and radiological health
Biologics Assessment and Research Center
The FDA invites comments on the draft guidance, in general, and on the following issues, in particular:
- Section 506J of the FD&C Act requires notifications “during or before” a public health emergency. Does the draft guidance provide sufficient clarity on what the FDA considers to be “before a public health emergency”? Is there any additional information that you think would be helpful? If so, what?
- Are there other situations or circumstances that could lead to a situation that could be considered “before a public health emergency”?
- Are there any circumstances where it is not clear whether you should notify the FDA? How could the FDA provide clarification?
- Should the FDA notify stakeholders when an event is considered “before a public health emergency,” and if so, how best should the FDA do it?
- How can the FDA better inform all stakeholders, including healthcare providers and patients, of shortages during or before a public health emergency?
- The FDA has offered to provide additional information during specific public health emergencies, which is intended to contain information specific to that public health emergency to help manufacturers provide notifications. Is there any specific information that you think should be conveyed in this additional information?
- How can the FDA best disseminate additional information during or before a public health emergency to manufacturers and other stakeholders?
- In the draft guidance document, Appendix A provides an example of additional information for an outbreak or pandemic that the FDA believes would be useful in assessing the general state of the market and helping to inform policy measures. potential mitigation. What additional information might be useful for other public health emergencies?
- The FDA recommends that manufacturers provide notification updates every two weeks, unless otherwise specified depending on the nature of the situation, including the expected time frame for recovery, even if the status remains unchanged. Please provide comments on this proposed frequency.
The Food and Drug Administration (FDA) publishes these guidelines to implement Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 USC 356j), as added by the ‘Section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), with respect to notifying the FDA of a shutdown or permanent disruption in the manufacture of a potentially harmful device. cause a significant interruption in the supply of this device during or before a public health event. emergency.
The FDA plays a vital role in protecting the United States from threats, such as emerging infectious diseases and other public health emergencies. Section 506J of the FD&C Act requires manufacturers to notify the FDA, during or before a public health emergency, of a permanent stop in the manufacture of certain devices or an interruption in the manufacture of certain devices that could cause a disruption. significant. in the supply of this device in the United States. This guide is intended to help manufacturers provide timely and informative notifications of changes in the production of certain medical devices that will help prevent or alleviate shortages of these devices. This guide also recommends that manufacturers voluntarily provide additional details to better ensure that the FDA has the specific information it needs to help prevent or mitigate shortages during or before a public health emergency.
The FDA is releasing this guide to assist stakeholders in the Agency’s implementation of Section 506J of the FD&C Act outside of the COVID-19 public health emergency, and will serve as a reference for notification information. under Section 506J of the FD&C Act during or in advance of any public health emergency. This draft guidance is not intended to replace guidance on COVID-19 public health emergencies, “Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device under Section 506J of the FD&C Act during the COVID- 19 Public Health Emergency, “which will be withdrawn at the end of the COVID-19 public health emergency. If these guidelines are finalized before the expiration or termination of the COVID-19 Public Health Emergency Declaration, the COVID-19 Public Health Emergency Guidelines will be applicable for 506J issues with respect to COVID- 19.