Medical Devices; Laboratory Developed Tests

Activity

American Medical 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 American Medical Association filed (1)

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.

• American Medical AssociationTHIS ORG

  1 filing · confidence 97%
• Advanced Medical Technology Associationtrade assoc.

  1 filing · confidence 97%
• Consumer Healthcare Products Associationtrade assoc.

  1 filing · confidence 97%