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Proposed LDT Rule Raises Many Questions but Provides Few Answers

FDA Law Blog

OCTOBER 6, 2023

The amended regulation would read as follows (revisions underlined): In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.

In-Vitro

In-Vitro Regulation Production Compliance

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N.

Regulation

Regulation In-Vitro Manufacturing Licensing

Clinical Research Informer

Proposed LDT Rule Raises Many Questions but Provides Few Answers

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

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