Medical supply shortages have been in the limelight since COVID-19 barreled into the U.S. and many manufacturers have been doing all they can to answer the call for more supplies. In response to this issue and recently passed legislation, the Food and Drug Administration (FDA) issued final guidance, “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.”
FDA issued this guidance to “clarify and make recommendations” about the scope of an amendment made to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made in the March 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The addition of section 506J to the FD&C Act (21 U.S.C. § 356j) requires manufacturers of medical devices “critical to public health during a public health emergency” or “for which the Secretary determines that information on potential meaningful supply disruptions of such device is needed during, or in advance of, a public health emergency” to notify FDA about either a permanent discontinuance or interruption of the manufacture of those devices.
Who Must Notify FDA
This notification requirement applies to manufacturers of certain categories of devices that have already received 510(k) clearance or are listed pursuant to section 510(j) of the FD&C Act. Importantly, this guidance states that notification requirements do not apply to manufacturers who have not received 510(k) clearance, but are distributing the device in light of FDA guidance about enforcement discretion. Manufacturers granted an Emergency Use Authorization (EUA) are encouraged to look at a particular device’s EUA terms and contact FDA with questions about the applicability of this guidance to those devices.
What Medical Devices Are Currently At Issue
The guidance clarifies which devices are impacted by this new notification requirement during the COVID-19 pandemic, as directly quoted below:
- Whether the device (with or without accessories) is life-supporting, life-sustaining, or intended for use in emergency medical care (examples could include ventilator and ventilator tubing, hemodialysis equipment, automated external defibrillator);
- Whether the device (with or without accessories) is intended for use during surgery (examples could include 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 COVID-19 (examples could include 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 COVID-19 pandemic compared to a similar period of time (examples could include personal protective equipment).
When to Notify FDA
The guidance instructs manufacturers to notify FDA at least six months in advance of a permanent discontinuance or a meaningful disruption in supply, or “as soon as practicable.” This latter timing requirement is interpreted by FDA as meaning “no later than 7 calendar days after the discontinuance or interruption in manufacturing occurs.” However, FDA interprets “interruptions in manufacturing” to include those that occur as a result of a decrease in manufacturing capability or increased demand.
FDA clarifies that a manufacturer “should base its reporting on its own capacity, supply, and orders, and should not consider other manufacturers’ or competitors’ capacities or assume capacities….” Notice is not required if there is an interruption in the manufacturing of components or raw materials so long as there is not a shortage of the device and manufacturing operations can resume within a time not to exceed one month. For testing equipment that can be used for multiple tests or procedures, an interruption that impacts even one of those tests should still be reported to FDA. FDA requests updates every two weeks after the initial notification until the shortage risk or interruption is resolved.
What Should Be in the Notice
FDA outlines the contents of a notification, which, according to the guidance, should include:
- Appropriate identifying information, such as the marketing submission holder name
- Marketing submission number (if applicable)
- Manufacturer name (if the manufacturer is different from the marketing submission holder)
- FDA Establishment Identifier (FEI) number
- Device name
- Product code
- Contact information
- Reason(s) for discontinuance or interruption
- Duration of interruption
- Information about how COVID-19 has impacted operations
- Production and manufacturing information
FDA provides an example form that sets out information that should be included and submitted via email to the agency (CDRHManufacturerShortage@fda.hhs.gov). Manufacturers are encouraged to submit a notification, even if all information is not available. Any information provided to FDA that is trade secret or confidential information will be treated as such by the agency, according to the guidance.
The guidance recommends that manufacturers contact FDA if there is uncertainty about whether a notice to the agency is required. Neither the new provision of the FD&C Act in section 506J nor this guidance states whether a manufacturer would be obligated to send a late notice of a supply disruption that a manufacturer became aware of after the enactment of this provision, but before this guidance was available.
Drug shortages have been the subject of legislation in the past and in recent FDA guidance. Title X of the Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in July 2012, assisted FDA in addressing the problem of drug shortages in the United States, requiring drug manufacturers to provide notice of product discontinuances and manufacturing interruptions. FDA has issued additional guidance for potential drug shortages during the COVID-19 public health emergency.
FDA hosted a webinar to discuss this new medical device guidance on May 11, 2020. Information about the webinar can be found here and presentation materials are typically made available after the webinar.
As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.