Medical Devices; Laboratory Developed Tests

Protection of human health or safety (TBT)

In vitro diagnostic products; Medical equipment (ICS code(s): 11.040); In vitro diagnostic test systems (ICS code(s): 11.100.10)

Link to ePing

11.040 - Medical equipment; 11.100.10 - In vitro diagnostic test systems; 11.040 - Medical equipment; 11.100.10 - In vitro diagnostic test systems

Human health; Human health

The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, the Food and Drug Administration is phasing out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. This phaseout policy includes enforcement discretion policies for specific categories of IVDs manufactured by a laboratory, including currently marketed IVDs offered as LDTs and LDTs for unmet needs. This phaseout policy is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance.This rule is effective 5 July 2024.Title 21 Code of Federal Regulations (CFR) Part 809This final rule and the proposed rule notified as G/TBT/N/USA/2054 are identified by Docket Number FDA-2023-N-2177. The Docket Folder is available on Regulations.gov at https://www.regulations.gov/docket/FDA-2023-N-2177/document and provides access to primary documents as well as comments received. Documents are also accessible from Regulations.gov by searching the Docket Number. 

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