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# Proposal to Clarify Medical Product Intended Use
- URL: https://www.fdaweb.com/proposal-to-clarify-medical-product-intended-use/
- Published: 2020-09-23T12:00:00.000Z
- Updated: 2026-09-14T16:29:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147714

*Federal Register* proposed rule: FDA has proposed to amend its medical product “intended use” regulations to describe the types of evidence relevant to determining whether a product is intended for use as a drug or device, including whether an approved or cleared medical product is intended for a new use. This action will also repeal and replace the portions of a final rule issued on 1/9/2017 that never became effective. The agency says the proposal is intended to provide direction and clarity to regulated industry and other stakeholders. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-09-23/pdf/2020-20437.pdf?ref=fdaweb.com).