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# FDA, HHS Withdraw Device Exemptions Notice
- URL: https://www.fdaweb.com/fda-hhs-withdraw-device-exemptions-notice/
- Published: 2021-04-15T12:00:00.000Z
- Updated: 2026-09-14T16:55:02.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149125

*Federal Register* notice: FDA and HHS are withdrawing a 1/15 notice that proposed exemptions for 83 Class 2 devices and one unclassified device from 510(k) premarket notification requirements. The agency says the previous administration did not consult with, involve or notify it before issuing the notice. Some of the proposed exemptions include device types that are indicated for a use in supporting or sustaining human life, such as product code NQY (“Ventilator, Continuous, Minimal Ventilatory Support, Home Use”). FDA says the determinations in the proposal were based solely on a tally of adverse events in its Manufacturer and User Facility Device Experience database (MAUDE), and the conclusion was based on the number of adverse events MAUDE tabulated. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-07760.pdf?ref=fdaweb.com).