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# Comments Sought on Informed Consent Exception for Diagnostics
- URL: https://www.fdaweb.com/comments-sought-on-informed-consent-exception-for-diagnostics/
- Published: 2017-08-22T12:00:00.000Z
- Updated: 2026-09-14T22:42:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139437

*Federal Register* notice: FDA is seeking comments on an information collection extension for “Medical Devices; Exception From General Requirements for Informed Consent.” In 2006, FDA issued an interim final rule to amend its regulations to establish a new 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. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-08-22/pdf/2017-17702.pdf?ref=fdaweb.com).