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# Info Collection on IVD Study Informed Consent
- URL: https://www.fdaweb.com/info-collection-on-ivd-study-informed-consent/
- Published: 2019-08-08T12:00:00.000Z
- Updated: 2026-09-15T01:42:42.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144730

*Federal Register* notice: FDA has submitted to OMB an information collection extension for “Guidance on Informed Consent for *In* Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable” (OMB Control Number 0910-0582). The document outlines the circumstances in which the agency intends to exercise enforcement discretion as to the informed consent regulations for clinical investigators, sponsors, and IRBs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-08-08/pdf/2019-17026.pdf?ref=fdaweb.com).