Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices

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Bob Dylan sang, “Tell Me, I’ve Got to Know.” In January 2022, the Food and Drug Administration said the same to the medical device industry when it issued a draft guidance, “Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device under Section 506J of the FD&C [Federal Food, Drug and Cosmetic Act].”1  The guidance is intended to: (a) help medical device manufacturers provide timely notice about changes in the production of certain products to help prevent or mitigate device shortages; (b) assist industry in understanding how FDA plans to implement Section 506J (21 U.S.C. § 356j) outside of the COVID-19 Public Health Emergency; and (c) serve as the baseline for information about notifications during, or in advance of, any public health emergency.2

This bulletin highlights some of the important elements of the draft guidance.

Summary

Who Must Notify
  • Manufacturers of the following devices must submit notifications of a permanent discontinuance or an interruption in manufacturing that is likely to lead to a meaningful supply disruption of that device:
    • devices that are critical to public health during a public health emergency, including those that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery; or
    • devices for which FDA determines information on potential meaningful supply disruptions is needed during, or in advance of, a public health emergency.
  • If manufacturers are not sure whether to notify, FDA recommends they evaluate the following circumstances to determine whether they produce devices for which a notification is required during, or in advance of, a public health emergency:
    • whether the device (with or without accessories) is life-supporting, life-sustaining, or intended for use in emergency medical care (e.g., extracorporeal life support, hemodialysis equipment, and automated external defibrillators);
    • whether the device (with or without accessories) is intended for use during surgery (e.g., cardiopulmonary bypass oxygenators and infusion pumps and tubing);
    • whether the device (with or without accessories and/or testing supplies) is used to diagnose, cure, treat, mitigate, or prevent a disease that is related to a pandemic or other public health emergency (e.g., specific supplies from diagnostic and serological specimen collection kits, pulse oximeters, and cardiac and other monitoring equipment); or
    • whether the device (with or without accessories) would be in higher-than-typical demand during the response to a pandemic or other public health emergency compared to a similar period of time (e.g., personal protective equipment and personal oxygen concentrator).
When to Notify
  • Manufacturers must submit a notification at least six months in advance of a permanent discontinuance or an interruption in manufacturing of a device that is likely to lead to a meaningful disruption in the supply of the device in the U.S. If that is not possible, notification should be done as soon as is practicable.
  • FDA considers “as soon as practicable” to mean that a manufacturer should notify FDA no later than seven calendar days after an interruption in manufacturing occurs or the manufacturer decides to permanently discontinue the device.
    • After the initial notification, FDA recommends that manufacturers provide updates every two weeks, including the expected timeline for recovery, even if the status remains unchanged.
    • The company should submit updates until the shortage risk has been resolved.
  • A “permanent discontinuance” is when the manufacturer stops making and distributing a product indefinitely for business or other reasons.
  • “Interruptions in manufacturing” means those that occur as a result of a decrease in manufacturing capability or an increase in demand due to the current or potential public health emergency.
  • “Meaningful disruption” is defined in the statute as “a change in production that is reasonably likely to lead to a reduction in the supply of a device by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand for its product.”
    • FDA stated that a manufacturer should base its reporting on its own capacity, supply, and orders, and not on others’ abilities.
      • The law makes clear that “meaningful disruption” does not include:
        •  [I]nterruptions in manufacturing of components or raw materials, so long as such interruptions do not result in a shortage of the device, and the manufacturer expects to resume operations in a reasonable period of time.”
      • FDA believes a “reasonable period of time” should not exceed one month.
        • “[I]nterruptions in manufacturing that do not lead to a reduction in procedures or diagnostic tests associated with a medical device designed to perform more than one procedure or diagnostic test.”
      • For devices designed to perform more than one procedure or diagnostic or serological test, manufacturers should provide notice of any interruption that could lead to a reduction in any of the procedures or testing capabilities (e.g., if a device can be used for five types of procedures, and the manufacturing interruption means only four types of procedures can be performed, the manufacturer should notify FDA).
        • “[I]nterruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing, so long as the manufacturer expects to resume operations in a short period of time, not to exceed six months.”
  • FDA explains that “during . . . a public health emergency” means the time period when the Health and Human Services Secretary (“HHS”) declares a public health emergency (and any renewals).
  • The phrase, “in advance of a public health emergency,” is the time period before the HHS may determine that a disease or disorder presents a public health emergency or that a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists.
    • If certain conditions exist before the occurrence of an outbreak or natural disaster that signal the potential for such event to occur and that may lead to the declaration of a public health emergency, this may be “in advance of a public health emergency.”
  • FDA recommends notice of a potential discontinuance or interruption if any of the following (not exhaustive) occur prior to a public health emergency being declared:
    • HHS authorizes assistance for research, investigations, demonstration, and studies into the causes, diagnosis, treatment, control, and prevention of a physical or mental disease;
    • HHS authorizes assistance in the prevention and suppression of communicable diseases;
    • HHS authorizes FDA to issue an Emergency Use Authorization for a drug, biological product, or device intended for use in an actual or potential emergency;
    • HHS accesses the Public Health Emergency Fund and/or has enabled the Centers for Disease Control and Prevention Director to access the Infectious Diseases Rapid Response Reserve Fund prior to declaring a public health emergency;
    • HHS determines that a disease or disorder, including a novel and emerging public health threat, is significantly likely to become a public health emergency for purposes of waiving the Paperwork Reduction Act;
    • other federal or state agencies determine that there is an actual or significant potential for a domestic emergency involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent; or
    • other federal or state agencies determine that there is a military emergency, or a significant potential for a military emergency involving a heightened risk to the U.S. military forces with a biological, chemical radiological, or nuclear agent or agents.
What Information to Include in 506J Notifications
  • Manufacturers must submit notifications of:
    • “a permanent discontinuance in the manufacture of the device (except for discontinuances as a result of an approved modification of the device);” or
    • “an interruption of the manufacture of the device that is likely to lead to a meaningful disruption in the supply of that device in the United States;” and
    • “the reasons for such discontinuance or interruption.”
  • The manufacturer should provide FDA with appropriate identifying information, such as marketing submission holder name, marketing submission number, manufacturer name (if manufacturer different from marketing submission holder), FDA Establishment Identifier number, device name, product code, and contact information.
  • FDA does not require manufacturers to have all of the information before submitting a notification; they can be updated at any time.
  • Manufacturers should submit additional information that could help FDA identify current supply chain pressures, including indications of:
    • manufacturing pressures (e.g., labor shortages, delays in raw material supply, temporary plant closures, packaging or sterilization concerns, other unforeseen circumstances that prevent fulfillment);
    • distribution pressures (e.g., shipping/transportation challenges, export/import challenges, procurement issues);
    • increased or projected increased demand (e.g., backorder, allocation, low fulfillment rates);
    • potential broader/connected interruptions (e.g., reliance on critical suppliers who are experiencing supply chain interruptions); and
    • actions or circumstances affecting software-enabled devices that may disrupt healthcare operations (e.g., device cybersecurity vulnerabilities).
  • Manufacturers should submit information that could help FDA better evaluate the overall state of the market and help identify potential mitigations, including:
    • potential prevention or mitigation strategies, including external communications; and
    • inventory and production capacity, including potential expansion capabilities (e.g., estimated market share, historic and current production capacity, maximum production volume).
      • FDA provided an example in an Appendix of the information to be included in a notification and examples of reasons for the discontinuance or interruption (as well as the other aforementioned voluntary information).
How to Notify
  • FDA’s website, “Contact the FDA About a Medical Device Supply Chain Issue,” available here, provides information about notification.
  • To notify the Center for Biologics Evaluation and Research or to ask questions about CBER-regulated devices, one can contact the cbershortage@fda.hhs.gov and include “Question” in the subject line of the email.
Failure to Notify
  • If a manufacturer does not provide the required notification within applicable timelines, FDA will issue a letter to the manufacturer informing of the failure.
    • The manufacturer must respond to FDA’s letter no later than 30 calendar days after issuance of FDA’s letter, providing the required information on the discontinuance or interruption.
    • No later than 45 calendar days of issuance of the letter to the manufacturer, FDA will make that letter and any response received available to the public on FDA’s website, with appropriate redactions to protect trade secrets or confidential commercial information.
    • FDA will not post the letter and response if it determines that the letter was issued in error or, after review of the manufacturer’s response, the manufacturer had a reasonable basis for not notifying FDA.
FDA Determination That a Device Is in Shortage
  • The statute defines “shortage” as “a period of time when the demand or projected demand for the device within the United States exceeds the supply of the device.”
    • FDA considers the information it has, including indications of supply disruptions received through notifications and voluntary manufacturer notifications, to assess whether there is a shortage.
How FDA Determines What Devices Are in Shortage
  • FDA will evaluate:
    • indications of supply disruptions
    • indications of distribution pressures
    • indications of demand or projected demand, such as availability issues reported from users
    • international factors (e.g., export restriction)
    • actions taken to prevent or mitigate shortages including, but not limited to, actions taken by manufacturers, FDA, or others
FDA’s List of Devices Determined to Be In Shortage
  • The statute requires the establishment and maintenance of an up-to-date list of medical devices that have been determined to be in shortage.
    • This list identifies medical devices for which there has been notification that manufacturing has been permanently discontinued.
    • FDA’s website contains a list that will reflect the categories of devices FDA has determined to be in shortage.
    • The list includes the category or name of the device in shortage, the name of each manufacturer, the reason for the shortage, and the estimated shortage duration.
Expedited Inspections and Reviews

If FDA concludes there is, or is likely to be, a shortage of a device, it will:

  • expedite the review of a regulatory submission that could help mitigate or prevent a shortage; or
  • prioritize and expedite an establishment inspection or re-inspection that could help mitigate or prevent such shortage.
Additional Information
  • FDA will accept any comment to the draft, but has specifically asked certain questions:
    • Whether the draft guidance provides sufficient clarity regarding what FDA considers to be “in advance of a public health emergency in the context of notification”?
    • Are there circumstances where it is unclear whether a company should notify FDA and how can it provide clarity?
    • Should the agency notify industry when an event is considered to be “in advance of a public health emergency” and, if so, how should FDA handle?
    • How can FDA be better informed regarding shortages during, or in advance of, a public health emergency?
    • Whether industry agrees with the agency’s recommendation that manufacturers provide updates to notifications every two weeks (unless circumstances dictate otherwise)?

AGG Observations

  • While the guidance is in draft form and is not legally binding, it represents FDA’s current thinking, and anyone in the medical device industry should review it carefully.
  • Interested parties should consider submitting comments and responding to the specific questions asked. We can help draft or review comments.
  • FDA has provided recommendations and definitions, and it appears the agency will work with medical device companies to mitigate against shortages, but it is looking to the industry to cooperate in turn.

[1] See www.fda.gov /media/155245/download.

[2] The 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.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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