Medical Devices; Laboratory Developed Tests

3 organizations filed 3 public comments on Medical Devices; Laboratory Developed Tests, at the Food and Drug Administration. The comment window closed 967d ago.

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.

Commenters (3)

• Advanced Medical Technology Associationtrade assoc.

  1 filing · confidence 97%
• American Medical Associationtrade assoc.

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

  1 filing · confidence 97%