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January 24, 2022

FDA Issues Draft Guidance on Discontinuance or Interruption of Manufacturing of Certain Devices Implementing CARES Act

Advisory

Introduction

On January 10, 2022, the US Food and Drug Administration (FDA or Agency) published a new draft guidance (Draft Guidance) on manufacturer’s requirements to report certain medical device shortages. The guidance implements section 506J of the Federal Food, Drug, and Cosmetic Act (FDCA) 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. The new Draft Guidance follows prior FDA guidance on notifying the Agency of a permanent discontinuation or interruption in manufacturing of a device during the COVID-19 public health emergency, last updated in November 2020 (November 2020 Guidance).1 While the November 2020 Guidance is specific to reporting during the COVID-19 pandemic, the new Draft Guidance is intended to serve as the baseline for notifications under section 506J during or in advance of any public health emergency. The new Draft Guidance is not intended to supersede the November 2020 Guidance, which will be withdrawn at the end of the COVID-19 public health emergency. Should the new Draft Guidance be finalized before the COVID-19 public health emergency expires, the November 2020 Guidance will remain applicable for COVID-19 related 506J reporting issues.

As further detailed herein, the new Draft Guidance helps clarify how FDA interprets the 506J notification requirements, including as pertains to who should submit 506J notifications, when to submit a 506J notification, and the information to include in a notification. The Draft Guidance does not take immediate effect, and it is being issued for comment purposes only. FDA is accepting public comments on the Draft Guidance through March 14, 2022.

The Draft Guidance parallels the reporting requirements for manufacturing shortages and discontinuations under the November 2020 Final Guidance, as well as preexisting pharmaceutical drugs and biologics reporting requirements that were in place before the COVID-19 pandemic. For more information on reporting requirements for pharmaceuticals and biologics, and to review the prior FDA guidance on medical device shortage reporting requirements, please see Arnold & Porter's previous Advisory on the matter.2

Background

Section 506J of the FDCA provides FDA with authorities to prevent or mitigate medical device shortages before or during a public health emergency. The provisions include requirements for manufacturers of certain medical devices deemed critical to public health to notify FDA "of a permanent discontinuance in the manufacture of the device" or "an interruption in the manufacture of the device that is likely to lead to a meaningful disruption in supply of that device in the United States"3 during a public health emergency. The Draft Guidance aims to provide clarification on how manufacturers should comply with these requirements.

The Draft 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 during or in advance of a public health emergency. If a manufacturer fails to submit the information required under section 506J, FDA is required to issue a letter informing the manufacturer of the failure.4 In addition, if FDA concludes there is, or is likely to be a shortage of a device, then inspections and submission review may be expedited to prevent such a shortage.5 The Draft Guidance clarifies and makes recommendations regarding three major notification requirements: (1) who must notify FDA, (2) when to notify FDA, and (3) what information to include in notifications. This Draft Guidance, and the currently in place November 2020 Guidance, were prompted by shortages caused by the pandemic.

Who Must Notify FDA Under 506J?

Section 506J of the FDCA requires manufacturers of two broad categories of medical devices to notify FDA of interruptions or permanent discontinuances in manufacturing: (1) medical devices that are critical to public health during a public health emergency; or (2) medical devices for which FDA determines information on potential significant supply disruptions is needed during a public health emergency.6 During or in advance of a public health emergency, FDA may recommend to manufacturers the types of devices FDA considers critical to the public during that public health emergency. For example, to help manufacturers determine Section 506J notification obligations during the COVID-19 pandemic, FDA has posted on its website a table of device types and corresponding product codes identifying devices FDA believes to be critical to public health during the COVID-19 emergency.

For purposes of the Draft Guidance, FDA interprets the term "manufacturer" to mean the entity that holds the medical device marketing submission authorization; if a medical device marketing submission is not required, the "manufacturer" is the entity responsible for listing the medical device under section 510(j) of the FDCA. The Draft Guidance explains that devices with marketing authorization from FDA, or that are listed pursuant to the FDCA 510(j) listing requirements, are subject to the section 506J notification requirements. FDA recommends that manufacturers consider the following criteria in determining whether they are required to submit 506J notifications to FDA:

  • Whether the device (with or without accessories) is life-supporting, life-sustaining, or intended for use in emergency medical care (e.g., ventilators and ventilator tubing, hemodialysis equipment, automated external defibrillator);
  • Whether the device (with or without accessories) is intended for use during surgery (e.g., cardiopulmonary bypass oxygenators, 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, reagents for extraction or PCR amplification or serological testing, pulse oximeters, 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).

The Draft Guidance further recommends that manufacturers uncertain whether to notify FDA about a device contact the Agency.7

When Should FDA Be Notified?

To provide FDA with sufficient time to address potential shortages of medical devices, section 506J of the FDCA requires manufacturers to notify FDA at least six months in advance of a permanent discontinuance or a manufacturing interruption that is likely to lead to a meaningful disruption in supply of the device. However, when such notice is not possible, section 506J requires that notice be provided "as soon as practicable."

For purposes of the Draft Guidance, FDA defines "as soon as practicable" to mean no later than seven calendar days after an interruption in manufacturing occurs or after the manufacturer decides to permanently discontinue the device, as applicable.8 FDA interprets “interruptions in manufacturing” to include 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. FDA recommends that manufacturers experiencing an increase in demand of a device relating to a response in a public health emergency (e.g., for the detection, treatment, or prevention of a disease relating to a pandemic) notify FDA of this interruption. In contrast, FDA clarifies that manufacturers experiencing normal variations in product demand or experiencing an increase in demand due to a temporary market response generally should not submit a notification.

Section 506J defines "meaningful disruption" 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."9 In the Draft Guidance, FDA explains that a manufacturer should base its reporting on its own capacity, supply, and orders, and should not consider other manufacturers’ or competitors’ capacities or assumed capacities, or what it understands about market demand for the device. Under section 506J, a meaningful disruption does not include: (i) interruptions in manufacturing due to matters such as routine maintenance or insignificant changes in manufacturing so long as the manufacturer expects to resume operations within 6 months; (ii) interruptions in manufacturing of components or raw materials so long as such interruptions do not result in shortage of the device and the manufacturer expects to resume operations in a reasonable period of time; and (iii) interruptions 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. The Draft Guidance explains that for devices designed to perform more than one procedure or diagnostic or serological test, manufacturers should provide notification of any interruption that could lead to reduction in any of the procedures or testing capabilities. For example, 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.

Additionally, FDA requests immediate notification if a manufacturer considers taking an action that may lead to a meaningful disruption in the supply of a device (e.g., transfer of ownership, holding production to investigate quality issue), or if a manufacturer is ordered by another United States government entity to take an action that diverts supply from the originally intended customer. To help FDA monitor the supply of critical medical devices, the Draft Guidance recommends that, after the initial 506J notification regarding an interruption in manufacturing, manufacturers provide FDA with status updates every two weeks until the risk of disruption or shortage has been resolved.10

As noted above, the section 506J reporting requirements apply during, or, in advance of, a public health emergency declared by the Secretary. FDA interprets “during . . . a public health emergency” to mean the time period when the Health and Human Services (HHS) Secretary declares a public health emergency under section 319 of the Public Health Service Act (PHSA). FDA interprets “in advance of a public health emergency” to mean the time period before the Secretary 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.11 If certain conditions exist prior to 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, FDA considers such conditions to be “in advance of a public health emergency.” When FDA becomes aware of such conditions that are in advance of a public health emergency, FDA may conduct outreach to, or otherwise notify, manufacturers to alert them of the situation and the applicability of section 506J.

Manufacturers should notify FDA of a potential discontinuance or interruption if any of the following occur prior to a public health emergency being declared:

  • HHS activates the National Disaster Medical System or deploys the Strategic National Stockpile.12
  • HHS authorizes assistance for research, investigations, demonstration, and studies into the causes, diagnosis, treatment, control, and prevention of a physical or mental disease under Section 301 of the PHSA.13
  • HHS authorizes assistance in the prevention and suppression of communicable disease under section 311 of the PHSA.14
  • HHS authorizes FDA to issue an Emergency Use Authorization (EUA) for a drug, biological product, or device intended for use in an actual or potential emergency.15
  • 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.16
  • 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.17
  • 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(s);18
  • 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 United States military forces with a biological, chemical, radiological, or nuclear agent or agents.19

The Draft Guidance further recommends manufacturers notify FDA of a chemical, biological, nuclear, and explosive event (CBRNE) or widespread treatment-resistant outbreaks to decrease the negative impact on patients and healthcare workers. Likewise, manufacturers experiencing an interruption during a public health emergency related to a localized event that has the potential to lead to a disruption of the supply of the device in the United States should notify the Agency under section 506J.20

What Information Should be Included in Notification?

In addition to section 506J(a)'s broad requirement that medical device manufacturers notify FDA of "the reasons" for any potential discontinuance or manufacturing interruption, FDA also seeks the following information:

  • Appropriate identifying information (e.g., marketing submission holder name, marketing submission number, manufacturer name, FDA Establishment Identifier (FEI) number, device name, product code, and contact information);
  • Reason(s) for discontinuance or interruption;
  • Duration of discontinuance or interruption;
  • Manufacturing pressures (labor shortages, delays in raw material supply, temporary plant closures, packaging or sterilization concerns, other unforeseen circumstances that prevent fulfillment) and distribution pressures (shipping/transportation challenges, export/import challenges, procurement issues);
  • Potential broader/connected interruptions (reliance on critical suppliers who are experiencing supply chain interruptions);
  • Actions or circumstances affecting software-enabled devices that may disrupt healthcare operations (device cybersecurity vulnerabilities or exploits);
  • Potential prevention or mitigation strategies; and
  • Inventory and production capacity and market share details.21

Manufacturers do not need to have all of the information before submitting a 506J notification as notifications can be updated at any time to include additional information.22 If a manufacturer does not notify FDA within the timelines specified in section 506J(b), FDA requests that manufacturers explain why such timeline was not possible. Where a manufacturer fails to provide notice of a permanent discontinuation or interruption as required by 506J or in accordance with the required timelines, FDA will issue a letter to that manufacturer informing the manufacturer of such failure.23 The manufacturer must respond to FDA’s letter within 30 calendar days after issuance with reasons for noncompliance and provide the required information on the discontinuance or interruption per section 506J(a) of the FD&C Act. Not 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, unless it is found the letter was sent in error.24 Directions on how to submit 506J notification can be found on the FDA’s website.

Conclusion

The COVID-19 health emergency has emphasized the importance of mitigating potential medical device shortages in the future, and the November 2020 Guidance along with the new Draft Guidance clarify important reporting requirements under section 506J of the FDCA. Medical device manufacturers should put formal procedures in place to ensure compliance with these new requirements. We will continue to monitor developments in this area and to assist clients in understanding and complying with these new guidelines.

© Arnold & Porter Kaye Scholer LLP 2022 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.

  1. See FDA, Guidance for Industry, 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 (November 2020) {“November 2020 Guidance”}.

  2. See Arnold & Porter’s previous June 2020 Advisory here.

  3. FD&C Act § 506J(a) (codified at 21 U.S.C. 356c(g)).

  4. See section 506J(e) of the FD&C Act.

  5. Draft Guidance at 2-3.

  6. Draft Guidance at 3.

  7. Contact CDRHManufacturerShortage@fda.hhs.gov for devices regulated by CDRH or cbershortage@fda.hhs.gov for devices regulated by CBER.

  8. Draft Guidance at 5.

  9. Section 506J(i)(1)(A) of the FD&C Act.

  10. Draft Guidance at 5.

  11. Draft Guidance at 7.

  12. Section 319 of the PHS Act.

  13. Section 301 of the PHS Act.

  14. Section 311 of the PHS Act.

  15. See “emergency use;” under section 564 of the FD&C Act.

  16. Section 219 of the PHS Act.

  17. Section 319(f) of the PHS Act.

  18. Section 564 of the FD&C Act.

  19. Id.

  20. Draft Guidance at 8.

  21. Draft Guidance at 9; see also Draft Guidance Appendix A for an example of information the FDA recommends be included in notification.

  22. Id.

  23. See section 506J(e)(1) of the FD&C Act.

  24. Id.

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