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# Comments on FDA Device Transition Guidance
- URL: https://www.fdaweb.com/comments-on-fda-device-transition-guidance/
- Published: 2022-03-29T12:00:00.000Z
- Updated: 2026-09-14T17:38:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151479

AdvaMed says it commends FDA efforts to develop a proposed transition plan for medical devices that fall within enforcement policies issued during the Covid-19 public health emergency. In its comment [letter](https://www.regulations.gov/comment/FDA-2021-D-1118-0015?ref=fdaweb.com), AdvaMed says the agency draft guidance “is a crucial step to help avoid disruption in device supply. At the same time and while we certainly cannot anticipate every scenario, we have included additional recommendations to provide needed clarification for FDA and industry and a smooth transition to support U.S. healthcare needs.” The association gives its answers to three questions posed by FDA in its request for comment.

The Medical Imaging & Technology Alliance [says](https://www.regulations.gov/comment/FDA-2021-D-1118-0021?ref=fdaweb.com) that in anticipation of the drawdown of the declared public health emergency and the end of the Covid-19 pandemic, “it will be essential that medical device manufacturers have clarity and flexibility regarding how to handle products brought to market under enforcement discretion policies. The transition plan outlined in this draft guidance would give manufacturers a suitable level of clarity and flexibility, and a long enough timeframe to transition devices into normal compliance or off the market.”