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HHS/FDA | RIN: 0910-AI85 | Publication ID: Spring 2023 |
Title: ●Medical Devices; Laboratory Developed Tests | |
Abstract:
This proposed rule would propose to amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: Undetermined |
CFR Citation: 21 CFR 809 | |
Legal Authority: 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 360c ... |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Eitan Bernstein Regulatory Counsel Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, WO 66, Silver Spring, MD 20993 Phone:240 402-9812 Email: eitan.bernstein@fda.hhs.gov |