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FDA Issues Draft Guidance on 506J Notifications for Medical Devices

  • 1.  FDA Issues Draft Guidance on 506J Notifications for Medical Devices

    Posted 11 days ago
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    Hi All,

    Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.

    This draft guidance, when finalized, is intended to:

    • Assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products to help prevent or mitigate shortages of such devices.
    • Assist stakeholders in the FDA's implementation of section 506J of the FD&C Act outside of the COVID-19 Public Health Emergency.
    • 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    This draft guidance is not intended to supersede the COVID-19 Public Health Emergency Guidance, "Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device under 506J of the FD&C Act during the COVID-19 Public Health Emergency," which will be withdrawn at the end of the COVID-19 Public Health Emergency.

    Note: This draft guidance is not for implementation at this time.

    Submit comments on this draft guidance

    This draft guidance will be open for public comments for 60 days at www.regulations.gov under docket number FDA-2022-D-0053.

    The FDA invites comments on the draft guidance, in general, and on the following questions, in particular: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 Does the draft guidance provide sufficient clarity regarding what the FDA considers to be "in advance of a public health emergency"?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.


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    Michael Roza CPA, CISA, CIA, MBA, Exec MBA
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