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 (FDA or Agency) is announcing the availability of a final guidance entitled "Laboratory Developed Tests: Small Entity Compliance Guide.'' The laboratory developed tests (LDT) final rule (notified as G/TBT/N/USA/2054/Add.1) amended FDA's 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. This small entity compliance guide (SECG) is intended to help small entities comply with applicable medical device regulations, consistent with the LDT final rule, including the phasing out of FDA's general enforcement discretion approach for LDTs so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs.This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on its title page: Center for Devices and Radiological Health, Center for Biologics Evaluation and Research.The announcement of the guidance is published in the Federal Register on 25 June 2024.89 Federal Register (FR) 53109, 25 June 2024:_x000D_ https://www.govinfo.gov/content/pkg/FR-2024-06-25/html/2024-13872.htm_x000D_ https://www.govinfo.gov/content/pkg/FR-2024-06-25/pdf/2024-13872.pdfThis notice of availability and previous actions notified under the symbol 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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