Proposed Rule Issued to Make Explicit that Lab Developed Tests (LDTs) Are Devices Under FDA Regulation; Comments Due Dec. 2
September 29, 2023 | |
Proposed Rule Issued to Make Explicit that Lab Developed Tests (LDTs) Are Devices Under FDA Regulation; Comments Due Dec. 2
The Food and Drug Administration (FDA) issued a proposed rule to amend it regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Food, Drug, and Cosmetic (FD&C) Act, including when the manufacturer of the IVD is a laboratory (press release). What is it. Historically, the FDA has exercised enforcement discretion over laboratory developed tests (LDT),… (Slifer, September 29, 2023) #Food and Drug Administration, #Medical Devices
