FDA Issues Guidance Implementing Section 506J of the FD&C Act as It Relates to Actual and Potential Device Shortages During COVID-19

On May 6, 2020, in response to the declared COVID-19 public health emergency, the Food and Drug Administration (“FDA” or the “Agency”) issued new guidance (“the Guidance”) to implement section 506J of the Federal Food, Drug and Cosmetic Act (“FD&C Act”) as it relates to actual and potential device shortages during the COVID-19 pandemic. The Guidance applies only to devices regulated by the Center for Devices and Radiological Health (“CDRH”), and the notification requirements outlined are intended to remain in effect only throughout the COVID-19 public health emergency. 

The Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), signed into law on March 27, 2020, amends the FD&C Act by adding section 506J to the statute. Section 506J provides FDA with new authority to help prevent or mitigate medical device shortages^[1] “during, or in advance of, a public health emergency” as declared by the Secretary of Health and Human Services under section 319 of the Public Health Service Act (“PHS Act”). Section 506J of the FD&C Act requires manufacturers to notify FDA of (1) any permanent discontinuance in the manufacture of certain devices, or (2) an interruption in the manufacture of such device that is likely to lead to a disruption in the supply of that device in the United States. The Guidance is intended to help manufacturers provide FDA timely, informative notifications about meaningful changes in the production of medical device products, and to assist the Agency in preventing or mitigating shortages of such devices during the COVID-19 public health emergency. The Guidance further recommends that manufacturers voluntarily provide additional details to FDA, so that it has the information needed to prevent and mitigate such shortages. 

See 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 (May 2020), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/notifying-cdrh-permanent-discontinuance-or-interruption-manufacturing-device-under-section-506j-fdc?utm_campaign=2020-05-06%20COVID-19%20Device%20Shortage%20Guidance&utm_medium=email&utm_source=Eloqua. 

Who Should Notify

Under section 506J, manufacturers^[2] of (1) devices that are critical to public health during the public health emergency,^[3] and (2) devices for which FDA determines information on potential meaningful supply disruptions is needed during a public health emergency, must notify FDA of interruptions, permanent discontinuances in manufacturing, or both. Specifically, if a manufacturer makes a device described in section 506J(a)(1)-(2) that has marketing authorization from FDA, or a device listed under section 510(j) of the FD&C Act, that manufacturer has an obligation under section 506J to notify FDA of covered manufacturing changes on the device. 

Together with a thorough review of sections 506J(a) and 510(j), FDA recommends that manufacturers evaluate the following circumstances when determining whether they are required to notify FDA: 

• Whether the device (with or without accessories) is life-supporting, life-sustaining, or intended for use in emergency medical care;^[4]
• Whether the device (with or without accessories) is intended for use during surgery;^[5]
• Whether the device (with or without accessories and/or testing supplies) is used to diagnose, cure, treat, mitigate, or prevent COVID-19;^[6] or
• Whether the device (with or without accessories) would be in higher-than-typical demand during the response to the COVID-19 pandemic compared to a similar period of time.^[7] 

The term “meaningful disruption” is defined in section 506J(i)(1)(A) of the FD&C Act 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.”^[8] FDA interprets this to mean that a manufacturer should base its reporting obligation on its own capacity, supply, and orders. To be sure, manufacturers should not consider other manufacturers’ real or assumed capacities, or what it understands about market demand for the device in determining their reporting obligation. 

When to Notify

With sufficient notice, FDA can work with manufacturers to potentially prevent and mitigate shortages, helping prevent negative impacts on patients and healthcare personnel. Accordingly, section 506J of the FD&C Act requires manufacturers to notify FDA at least six months before (1) permanent discontinuance^[9] in manufacturing or (2) interruption in manufacturing of a device that is “likely to lead to a meaningful disruption in supply of the device in the United States.” If the six-month timeframe is not possible, manufacturers should notify FDA “as soon as practicable.” In the Guidance, FDA advises that “as soon as practicable” means no later than seven (7) calendar days after the discontinuance or interruption in manufacturing occurs. After an initial notice of an interruption, FDA recommends that manufacturers provide updates every two weeks until the shortage risk has been resolved, and should include in their notice the expected timeline for recovery (even if the status remains unchanged). 

In addition to the reporting requirements on permanent discontinuance and meaningful disruptions, FDA further requests immediate notification if the manufacturer (1) is considering taking an action that may lead to such disruption in the supply chain;^[10] or (2) is ordered by another U.S. government entity to take action that diverts supply from the originally intended customer. 

Information to Include in Notification

Manufacturers anticipating a permanent discontinuance or interruption in manufacture (likely to lead to a meaningful disruption in the supply of that device) must notify FDA of such interruptions and discontinuances as well as the reasons for them. When providing such information, FDA further requests manufacturers supply the Agency with: 

• Appropriate identifying information and manufacturer name (if different than marketing submission holder);
• Marketing submission number (if applicable);
• FDA Establishment Identifier number;
• Device name and product code;
• Contact information of reporter, including name, email, and phone number;
• The reason(s) for and estimated duration of discontinuance or interruption;
• COVID-19-specific impacts;
• Mitigation plans (if applicable); and
• Information on production capacity and market share. 

FDA recommends that manufacturers do not delay notifying the Agency until all information is available; instead, FDA requests that initial notices be submitted as soon as practicable, and notifications be updated as information becomes available. 

FDA guidance documents reflect FDA’s current thinking on a subject and are recommendations, unless specific regulatory or statutory requirements are cited. While this Guidance was issued without a prior comment period, FDA will be accepting public comments on it going forward. The Guidance reflects FDA’s intent to clarify section 506J of the FD&C Act and make recommendations regarding (i) who must notify FDA, (ii) how to do so, and (iii) what information to include in the notification, throughout the COVID-19 public health emergency. 

We note that government orders on the local, state, and federal level are changing every day, and the information contained herein is accurate only as of the date set forth above. 

All entities should consult legal counsel for compliance issues and questions related to rapidly evolving COVID-19 legislation and policy.  

******************************************************************************

For further information or questions on the new Guidance or reporting obligations under the Food, Drug & Cosmetic Act, please contact the Winston partners listed below, or your Winston relationship attorney.

 View all of our COVID-19 perspectives here. Contact a member of our COVID-19 Legal Task Force here.

---

^[1] _{“Shortage” is defined as “a period of time when the demand or projected demand for the device within the United States exceeds the supply of the device.” See section 506J(i)(2) of the FD&C Act.}

^[2] _{For purposes of this guidance, FDA interprets the term “manufacturer” to mean the entity that holds the medical device marketing submission authorization, or, if such authorization is not required, the entity responsible for listing the medical device under section 510(j) of the FD&C Act.}

^[3] _{Including devices that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery.}

^[4] _{Examples could include but are not limited to ventilators and ventilator tubing, hemodialysis equipment, and automated external defibrillators.}

^[5] _{Examples could include but are not limited to cardiopulmonary bypass oxygenators, infusion pumps, and tubing.}

^[6] _{Examples could include but are not limited to 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.}

^[7] _{Examples could include but are not limited to personal protective equipment.}

^[8] _{“Meaningful disruption” does not include: interruptions in manufacturing due to routine maintenance or insignificant changes in manufacturing, so long as the manufacturer expects to resume operations in no longer than six months; interruptions due to manufacturing of raw materials, so long as such interruptions do not lead to a shortage of the device; or 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. FDA interprets “interruptions in manufacturing” to include those that occur as a result of a decrease in manufacturing capability or increased demand.}

^[9] _{FDA interprets a “permanent discontinuance” to be a decision by the manufacturer to cease manufacturing and distributing a product indefinitely for business or other reasons. All such discontinuances must be reported within the timeframe prescribed by section 506J(b) of the FD&C Act.}

^[10] _{E.g., holding production to investigate a quality issue or initiating transfer of ownership.}