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# Comments on Discontinuance/Interruption Guidance
- URL: https://www.fdaweb.com/comments-on-discontinuance-interruption-guidance/
- Published: 2022-04-12T12:00:00.000Z
- Updated: 2026-09-14T17:40:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151577

The Medical Imaging and Technology Alliance (MITA) says an FDA draft guidance on notifying the agency in advance of a public health emergency about the permanent discontinuance or interruption in manufacturing a device under Section 506J of the Federal Food, Drug, and Cosmetic Act should be “significantly narrower in scope.” The comment [letter](https://www.regulations.gov/comment/FDA-2022-D-0053-0010?ref=fdaweb.com) says the guidance should be aligned with the original legislative intent and apply regulatory efficiency and least burdensome provisions.

“This guidance could lead to manufacturers over-reporting, overburdening manufacturers and agency staff, or leading to irrelevant information being reported to the agency,” MITA says. “We recommend that the agency publish and accept comment on a list of the specific devices it has identified as ‘critical to public health during a public health emergency, or for which FDA determines information on potential meaningful supply disruptions is needed during a public health emergency.’”

The Cook Group [says](https://www.regulations.gov/comment/FDA-2022-D-0053-0008?ref=fdaweb.com) the guidance “should give visibility as to how the agency intends to support market availability for medical technology, beyond shortage reporting merely as a data repository. It would be helpful to understand FDA’s current thinking of its role in logistics when there is a critical raw material or component shortage to be mitigated.”

In its [response](https://www.regulations.gov/comment/FDA-2022-D-0053-0009?ref=fdaweb.com), AdvaMed says it is vital for FDA to publish a list of procodes that are subject to the Section 506J reporting requirements. “Despite FDA’s attempts to clarify,” the association says, “it is not and will not always be clear whether a device meets the standard under Section 56J(a)(1).”

AdvaMed says that manufacturer confusion over the scope of devices subject to the reporting requirements may lead manufacturers to over-report, overwhelm FDA’s new medical device supply chain operation, provide no value where a device shortage does not exist, and is inconsistent with the agency’s least burdensome principles.

Finally, the Medical Device Manufacturers Association [says](https://www.regulations.gov/comment/FDA-2022-D-0053-0007?ref=fdaweb.com) FDA should clearly state which device types the agency believes are critical to be notified under Section 506J. It also asks that FDA communicate publicly when the country is “in advance of a public health emergency” since it can be difficult or nearly impossible for companies to make that determination on their own with the limited information they have.