← Advanced Medical Technology Association
FDARulemakingFDA-2023-N-2177

Medical Devices; Laboratory Developed Tests

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Advanced Medical Technology Association filings
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Advanced Medical Technology Association filed 1 comment on this docket between Dec 22, 2023 and Dec 22, 2023. 2 other organizations filed here. The comment window closed 967d ago.

What Advanced Medical Technology Association filed (1)

Dec 22, 2023· Comment from Advanced Medical Technology Association (AdvaMed)· FDA-2023-N-2177-6481

Filed on regulations.gov — full text not in the inline record.

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Abstract

The Food and Drug Administration 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 when the manufacturer of the IVD is a laboratory. We are also proposing a policy intended to phase out our general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by laboratories would generally fall under the same enforcement approach as other IVDs. This phaseout is intended to better protect the public health by helping assure the safety and effectiveness of LDTs and may foster innovation.

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Co-filers (2)

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