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# Proposed Rule on Lab-developed Tests
- URL: https://www.fdaweb.com/proposed-rule-on-lab-developed-tests/
- Published: 2023-10-03T12:00:00.000Z
- Updated: 2026-09-14T19:00:16.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155465

*Federal Register* notice: FDA is proposing to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including for when the IVD is a laboratory-developed test (LDT). The agency is also proposing a policy under which it intends to phase out its general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory would generally fall under the same enforcement approach as other IVDs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-10-03/pdf/2023-21662.pdf?ref=fdaweb.com).