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# Comments Sought on Device Exceptions for Informed Consent
- URL: https://www.fdaweb.com/comments-sought-on-device-exceptions-for-informed-consent/
- Published: 2017-04-18T12:00:00.000Z
- Updated: 2026-09-14T22:18:21.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138473

*Federal Register* notice: FDA is requesting comments on an information collection for its interim final rule “Medical Devices; Exception From General Requirements for Informed Consent — 21 CFR 50.23.” The information collection requests certain information to allow an exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency took this action because it was concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-04-18/pdf/2017-07768.pdf?ref=fdaweb.com).