FDA finalizes guidance on reporting medical device shortages

The US Food and Drug Administration (FDA) issued finalized guidance on its requirements for notifying the agency of potential medical device shortages during or in advance of a public health emergency (PHE). The new version, published 7 January, updates a list of devices that are subject to mandatory notification and adds a new section on its acceptance of voluntary notification.

“This guidance finalizes a list of device product codes for which a manufacturer of such devices is required to notify FDA in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) (hereafter referred to as the “506J Device List”) and clarifies that manufacturers may submit voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a public health emergency,” FDA announced.

The guidance implements portions of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which was signed into law on 27 March 2020. CARES amends the FD&C Act by adding a new section 506J which gives the FDA new authority to help prevent or mitigate shortages of medical devices during or in advance of a public health emergency.

Under section 506J, manufacturers of devices that are critical to public health during a PHE must submit notifications, including those that are

life supporting;
life-sustaining;
intended for use in emergency medical care; or
devices for which FDA determines information on potential meaningful supply disruptions is needed in advance of a PHE.

The finalized version revises the draft published in November 2023 (RELATED: FDA publishes final guidances on device shortage reporting, computational modeling, Regulatory Focus 17 November 2023).

The revisions include a new list of devices with product codes that are subject to mandatory reporting. FDA stated that Section 2514(c)of the FY 2023 omnibus spending bill directed FDA to issue guidance and to “list each product code for which a manufactured device is required to notify the Secretary in accordance with section 506J.” Additionally, a website has been established to list the devices subject to notification. The list "will evolve over time" and will be updated periodically, FDA noted.

Another change is the addition of a new section on voluntary notifications. Section 506J(h) of the FD&C Act stipulates that device manufacturers can inform the FDA at any time outside of a public health emergency whether their devices are subject to discontinuance or interruption.

“FDA interprets section 506J(h) to clarify that FDA may receive additional notifications about medical devices at any time, unrelated to the declaration or potential declaration of a PHE,” said the guidance. “FDA has always accepted voluntary submissions of information across many topics, including device supply chain matters. Section 506J(h) does not alter FDA’s ability or authority to receive voluntary information on supply chain or other matters.”

FDA recommends that manufacturers submit a 506J notification if they are experiencing any of the following:

Unplanned manufacturing challenges such as labor shortages, delays in raw material supply, temporary plant closures, or sterilization concerns, that prevent the manufacturer from meeting demand;

Unplanned distribution challenges such as shipping or transportation delays, export or import challenges, or procurement issues;

FDA encourages submission of voluntary notifications within seven calendar days after the occurrence of a manufacturing interruption.

Guidance

FDA finalizes guidance on reporting medical device shortages

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