Who must notify

Section 506J of the Federal Food, Drug, and Cosmetic Act (FDCA) requires medical device manufacturers to notify FDA, during “or in advance of” a public health emergency under section 319 of the Public Health Service Act (PHSA), 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 U.S. This applies to manufacturers of 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

• for which FDA determines information on potential meaningful supply disruptions is needed during, or in advance of, a public health emergency.

During the COVID-19 pandemic, FDA created a table of device types and corresponding product codes identifying devices that FDA believes to be critical to the public health during a public health emergency under the FDCA, which manufacturers should consider to determine whether they are required to notify FDA. However, the agency’s latest draft guidance does not only apply to the current public health emergency, and it is not intended to supersede the COVID-19 Public Health Emergency guidance “Notifying CDRH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in Manufacturing of a Device under 506J of the FD&C Act during the COVID-19 Public Health Emergency,” which will be withdrawn at the end of the COVID-19 Public Health Emergency, but will apply to future public health emergencies and the period when one may be emerging.

For manufacturers who are unsure whether they are required to submit a 506J notification, FDA recommends they evaluate the following circumstances to determine whether they manufacture 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 (examples could include extracorporeal life support, hemodialysis equipment, and automated external defibrillators);
• Whether the device (with or without accessories) is intended for use during surgery (examples could include 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 (examples could include 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 (examples could include personal protective equipment and personal oxygen concentrators).

These considerations will need to flexible to cover the needs of the next public health emergency.

When to notify

Manufacturers who must submit a 506J notification should do so at least six months in advance of a permanent discontinuance in manufacturing of a device or an interruption in manufacturing of a device that is likely to lead to a meaningful disruption in supply of the device in the U.S. If that timeframe is not possible, notification should be done “as soon as is practicable,” according to the draft guidance. FDA says it considers “as soon as practicable” to mean that a manufacturer should notify FDA no later than 7 calendar days after an interruption in manufacturing occurs, or no later than 7 calendar days after the manufacturer decides to permanently discontinue the device, as applicable. FDA defines a “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” and advises manufacturers to not consider the ability of other manufacturers to fill the void.

As already codified in the FDCA, the draft guidance spells out how FDA interprets a “permanent discontinuance” to mean when the manufacturer ceases manufacturing and distributing a product indefinitely for business or other reasons; and how 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. Importantly, this is not an across the board obligation to notify FDA of any discontinuance or interruption in manufacturing, but rather is an obligation that is tied to a current or emerging public health emergency.

The draft guidance also explains the timelines for the terms “during…a public health emergency” and “in advance of a public health emergency.” Notably, FDA says that “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.’” For example, 506J notification is required if:

• HHS activates the National Disaster Medical System or deploys the Strategic National Stockpile without yet determining a public health emergency;
• 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; or
• HHS authorizes assistance in the prevention and suppression of communicable diseases under section 311 of the PHSA.

Additional examples are provided in the draft guidance.

The draft guidance also notes that if the circumstances giving rise to a manufacturer’s 506J notification change after notifying FDA, the manufacturer should notify FDA of this change in status as well and also recommends updates be provided every six weeks.

What information to include in 506J notifications

FDA recommends that manufacturers submitting 506J notifications include additional information that could inform FDA of 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 330 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 or exploits).

In addition, FDA advises manufacturers to submit information that could help FDA better assess the overall state of the market and help inform potential mitigations, including a) potential prevention or mitigation strategies, including stakeholder and customer communications; and b) inventory and production capacity, including potential expansion capabilities (e.g., estimated market share, historic and current production capacity, maximum production volume).

The draft guidance recommends that manufacturers not delay notifying FDA until all information is available, but instead recommends that they provide initial 506J notification as soon as is practicable and then share additional information as it becomes available.

Appendix A of the draft guidance provides an example of the information that FDA recommends be included in a 506J notification, and examples of reasons for the discontinuance or interruption, as well as other voluntary information that could be included.

Last, the draft guidance also contains information on how FDA determines which devices are in shortage, its list of devices in shortage, and expected reviews and inspections for devices in shortage.

FDA authority to assist in mitigating shortages

The FDA has new authorities it can use to help prevent or mitigate device shortages both during a public health emergency or even in advance. FDA is required to maintain a publicly available, up to date list of devices it has determined to be in shortage. Currently on the list are clinical chemistry products, dialysis related products, general ICU/hospital products, hematology products, infusion pumps and related accessories, microbiology products, needles and syringes, personal protective equipment, sterilization products, testing supplies and equipment, ventilation related products and vital signs monitoring products. The Cares Act granted FDA authority to do more than simply log and collate products for which it has received notification. If the Secretary concludes that there is, or is likely to be, a shortage of a device, inspections, as well as review of submissions, may be prioritized and expedited to help mitigate or prevent shortages.

FDA also has the authority to issue letters in cases where the agency believes a manufacturer has failed to submit the necessary notification and where, upon review the agency concludes that there was indeed a failure, the agency plans to make the redacted correspondence publicly available on its website.

Relatedly, in March 2020, the President of the United States issued an Executive Order on “Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19,” which invokes the Defense Production Act of 1950 (DPA) to confer upon the President a broad set of authorities to influence domestic industry in the interest of national defense. Specifically, the EO determines that personal protective equipment and ventilators, as well as other health and medical resources that may be identified by the Secretary of Health and Human Services (HHS) are “scarce and critical material[s] essential to the national defense” such that the Presidency can exercise its powers under the DPA to control the general distribution of such materials in the marketplace.

Under the Defense Priorities and Allocation System (DPAS), which are the implementing regulations for the DPA, several federal agencies may issue “rated orders,” which are priority ratings that are assigned to government contracts that are needed to support certain approved programs, such as the government’s response to COVID-19. In addition, the DPA allows the government to issue “allocation” orders “when there is insufficient supply of a material, service, or facility to satisfy national defense requirements through the use of the priorities authority or when the use of the priorities authority would cause a severe and prolonged disruption in the supply of materials, services, or facilities available to support normal U.S. economic activities.” FDA may utilize this authority to respond to shortages, and may issue rated orders in response to notifications sent to the agency under Section 506J of the FDCA.

Next steps

While drug manufacturers have had obligations to notify FDA of drug shortages, medical device manufacturers have not had such an obligation until recently when the world was confronted with the COVID-19 pandemic. The COVID-19 pandemic has stretched the nation’s health care infrastructure in ways that challenge the limits of disaster recovery plans and the ability of manufacturers to pivot and adapt. While the industry has stepped up in many ways to continue to supply product, issues such as the explosive needs for devices, supply chain shortage, worker shortages, and the duration of the pandemic have made it a reality that the industry may not be able to supply all of the medical devices it would like.

While the COVID-19 pandemic is not the first public health emergency this nation has had to confront, it has forced the industry and the nation to think hard about preparedness and confront the reality that there may well be another one – likely a very different one – in the future. As such, company’s should reconsider their disaster recovery plans and whether there is a need for procedures that only get activated during a public health emergency for which their products are in great need, like this one for reporting discontinuations and interruptions in manufacturing. Additionally, manufacturers should consider what measures can be taken to strengthen the supply chain and apply the learnings from the challenges faced in this pandemic.

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

• Whether the draft guidance provides sufficient clarity regarding what the FDA considers to be “in advance of a public health emergency,” and whether any other situations should be considered in defining this term.

• How FDA could notify stakeholders when an event is considered to be "in advance of a public health emergency,” or regarding shortages.

• Any circumstances where it is unclear whether a device manufacturer should submit a 506J notification.

• How FDA can best disseminate supplemental information during or in advance of a public health emergency to manufacturers and other stakeholders.

• FDA’s recommendation 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.

FDA is accepting comments on the draft guidance through March 11. If you have any questions on 506J notifications, would like assistance in strengthening your infrastructure, or may wish to submit a comment, please contact any of the authors of this alert or the Hogan Lovells attorney with whom you generally work.

Authored by Jodi K. Scott and Randy Prebula