FDA Seeks Comments on Device Shortage Notification Guidelines

Posted on January 10, 2022 | Through Michael Mezher

The U.S. Food and Drug Administration (FDA) on Monday released draft guidance on new notification requirements for reporting medical device discontinuations and manufacturing disruptions created under the FDA. Coronavirus Aid, Relief and Economic Security Act (CARES Act).

The CARES Act was enacted in the early months of the COVID-19 pandemic and, for the first time, established requirements for medical device manufacturers to notify the FDA of permanent disruptions or manufacturing disruptions that could result in shortages of critical medical devices during or before a public health emergency.

In May 2020, the FDA issued immediately effective guidance explaining these requirements in the context of the COVID-19 pandemic, and in November 2020 the agency revised the guidance to further clarify the factors it used to determine if a device is in short supply. (RELATED: CDRH Explains Notification Requirements for Device Shortages Under the CARES Act, Regulatory guidance May 6, 2020; Device shortage guidance receives COVID update from FDA, Regulatory guidance December 2, 2020)

With the newly released draft guidance, the FDA seeks to promulgate guidance on device notification requirements set forth in Section 506J of the Federal Food, Drug and Cosmetic Act this would apply beyond the current pandemic. The agency is seeking comments on the draft guidelines and has provided a list of nine questions on which it would like specific feedback.

The FDA explains that the guidance is not intended to replace its similarly titled COVID-era guidance on reporting device or manufacturing disruptions, which contains specific recommendations relating to the current pandemic. In the event that the new draft guidelines are finalized before the end of the COVID-19 public health emergency declaration, the agency says the COVID-19 public health emergency guidelines “will be applicable to issues related to 506J regarding COVID-19”.

As part of its implementation of the new requirements during the COVID-19 pandemic, the FDA has released a list of medical devices that are in short supply or have been discontinued. In the new draft guidelines, the agency notes that it may use the same or a different approach during a future public health emergency. (RELATED: FDA Lists Shortage Medical Devices Under CARES Authority, Regulatory guidance August 14, 2020)

The agency recommends that manufacturers update it on manufacturing disruptions for any device for which a 506J notification was made every two weeks after the initial notification, unless otherwise specified. This would mark a change from COVID-era guidelines that allow six weeks between updates.

The new guidance also contains two new subsections that further expand on two of the key elements of the reporting requirements.

First, the agency clarifies its interpretation of the terms “permanent disruptions, manufacturing disruptions, and significant supply disruptions.”

While the definition of “permanent disruption” is fairly straightforward, the agency’s understanding of manufacturing disruptions and significant supply disruptions is more nuanced.

The guidance provides examples of both situations. For example, manufacturing disruptions “include those that occur as a result of a decrease in manufacturing capacity or an increase in demand due to the current or potential public health emergency.” Here, the agency distinguishes between companies experiencing an increase in demand for a device as a direct result of an emergency, which must notify the agency of the disruption, and “manufacturers experiencing a normal variation in demand for products” and those “experiencing an increase in demand”. due to a temporary market reaction”, which generally does not have to submit a notification.

The guidelines also explain how the FDA interprets “prior to a public health emergency.”

“If certain conditions exist prior to the onset of an epidemic or natural disaster that signal the possibility of such an event occurring and that may lead to the declaration of a public health emergency, the FDA considers these conditions are “prior to a public health emergency,” writes the FDA.The agency further notes that it can conduct outreach and inform manufacturers to alert them to such a situation.

FDA, Federal Register Notice

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