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GUIDANCE DOCUMENT

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act Draft Guidance for Industry and Food and Drug Administration Staff January 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-0053

Docket Number:
FDA-2022-D-0053
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

The FDA invites comments on the draft guidance, in general, and on the following questions, in particular:

  • Section 506J of the FD&C Act requires notifications "during, or in advance of" a public health emergency. Does the draft guidance provide sufficient clarity regarding what the FDA considers to be "in advance of a public health emergency"? Is there additional information that you believe would be helpful? If so, what?
  • Are there other situations or circumstances that could lead to a situation that could be considered to be "in advance of a public health emergency"?
  • Are there circumstances where it is unclear whether you should notify the FDA? How could the FDA provide clarity?
  • Should the FDA notify stakeholders when an event is considered to be "in advance of a public health emergency", and if so, how should the FDA best do so?
  • How can the FDA keep all stakeholders, including healthcare providers and patients, better informed regarding shortages during or in advance of a public health emergency?
  • The FDA has proposed providing supplemental information during specific public health emergencies, which is intended to contain information specific to that public health emergency to assist manufacturers in providing notifications. Is there specific information that you believe should be conveyed in such supplemental information?
  • How can the FDA best disseminate supplemental information during or in advance of a public health emergency to manufacturers and other stakeholders?
  • In the draft guidance document, Appendix A displays an example of supplemental information for an epidemic or pandemic that the FDA believes would be helpful to assess the overall state of the market and help inform potential mitigations. What additional information might be helpful for other public health emergencies?
  • The FDA recommends that manufacturers provide updates to notifications every two weeks unless otherwise indicated based on the nature of the situation, including the expected timeline for recovery, even if the status remains unchanged. Please provide feedback on this proposed frequency.

The Food and Drug Administration (FDA or Agency) is issuing this guidance to implement section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356j), as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), as it relates to notifying FDA of a permanent discontinuance or interruption in the manufacturing of a device that is likely to lead to a meaningful disruption in the supply of that device during or in advance of a public health emergency.

FDA plays a critical 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 FDA, during or in advance of a public health emergency, of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States. This guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products that will help prevent or mitigate shortages of such devices. This guidance also recommends that manufacturers voluntarily provide additional details to better ensure FDA has the specific information it needs to help prevent or mitigate shortages during or in advance of a public health emergency.

FDA is issuing this guidance 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 the baseline for information about notifications under section 506J of the FD&C Act during or in advance of any public health emergency. This draft guidance is not intended to supersede the COVID-19 Public Health Emergency Guidance, "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. Should this guidance be finalized before the COVID-19 public health emergency declaration expires or is terminated, the COVID-19 Public Health Emergency Guidance will be applicable for 506J related issues with respect to COVID-19.

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