FDA seeks comment on device shortage reporting guidance

Regulatory NewsRegulatory News | 10 January 2022 |  By 

The US Food and Drug Administration (FDA) on Monday released draft guidance on the new notification requirements for reporting medical device discontinuances and manufacturing interruptions created under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).
The CARES Act was signed into law in the early months of the COVID-19 pandemic and, for the first time, established requirements for medical device makers to notify FDA of permanent discontinuances or manufacturing interruptions that could lead to shortages of critical medical devices during or in advance of a public health emergency.
In May 2020, FDA issued an immediately effective guidance explaining those requirements in context of the COVID-19 pandemic, and in November 2020, the agency revised the guidance to provide further clarity on what factors it used to determine whether a device is in shortage. (RELATED: CDRH explains notification requirements for device shortages under CARES Act, Regulatory Focus 6 May 2020; Device shortage guidance gets a COVID update from FDA, Regulatory Focus 2 December 2020)
With the newly issued draft guidance, FDA seeks to promulgate guidance on the device notification requirements set out in Section 506J of the Federal Food, Drug, and Cosmetic Act that would apply beyond the current pandemic. The agency is seeking comment on the draft guidance and has provided a list of nine questions it would like specific input on.
FDA explains that the guidance is not meant to supersede its similarly titled COVID-era guidance on reporting device discontinuances or manufacturing interruptions, which contains specific recommendations pertaining to the current pandemic. In the event that the new draft guidance is finalized before the COVID-19 public health emergency declaration ends, the agency says the COVID-19 public health emergency guidance “will be applicable for 506J related issues with respect to COVID-19.”
As part of its implementation of the new requirements during the COVID-19 pandemic, FDA published a list of medical devices that are in shortage or have been discontinued. In the new draft guidance, the agency notes that it may use the same or a different approach in a future public health emergency. (RELATED: FDA lists medical devices in shortage under CARES authority, Regulatory Focus 14 August 2020)
The agency recommends that manufacturers update it on manufacturing interruptions for any device for which a 506J notification has been made every two weeks after the initial notification, unless otherwise indicated. This would mark a change from the COVID-era guidance which allows for six weeks between updates.
The new guidance also contains two new subsections that further expand on two of the key components of the reporting requirements.
First, the agency elaborates on its interpretation of the terms “permanent discontinuances, interruptions in manufacturing and meaningful disruptions in supply.”
While the definition of “permanent discontinuance” is fairly straightforward, the agency’s understanding of manufacturing interruptions and meaningful disruptions in supply are more nuanced.
The guidance provides examples of both circumstances. For instance, interruptions in manufacturing “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.” Here, the agency distinguishes between companies experiencing an increase in demand for a device as a direct result of an emergency, which should notify the agency of the interruption, and “manufacturers experiencing normal variation in product demand” and those “experiencing an increase in demand due to a temporary market response,” which generally should not submit a notification.
The guidance also explains how FDA interprets “in advance of a public health emergency.”
“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,’” FDA writes. The agency further notes that it may conduct outreach and notify manufacturers to alert them to such a situation.
FDA, Federal Register Notice


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Tags: 506J, Shortages

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