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HIV Testing Access to Get Boost With FDA Reclassifications

May 13, 2022, 4:43 PM

Manufacturers of certain HIV tests will face less stringent premarket requirements under a final Food and Drug Administration order issued Friday reclassifying these devices.

The order allows makers of nucleic acid, antigen, and antibody tests used for the detection of HIV to submit applications through one of the more commonly used pathways for devices: the premarket notification, or 510(k), pathway. These tests, which have traditionally been required to go through a more strict application approval process, can now be approved for marketing more quickly, potentially leading to more patient testing.

Public comments on the change, which was first proposed in ...

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