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# FDA Reclassifying Certain HIV Tests
- URL: https://www.fdaweb.com/fda-reclassifying-certain-hiv-tests/
- Published: 2020-02-21T12:00:00.000Z
- Updated: 2026-09-14T16:04:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5146143

*Federal Register* proposed order. FDA is proposing to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid diagnostic and supplemental tests, Class 3 devices with the product code MZF, into Class 2 (special controls), subject to premarket notification. FDA’s decision to reclassify the devices is intended to reduce the regulatory burdens associated with the devices. Once finalized, the devices will no longer be required to have an approved PMA, and instead can be marketed under the 510(k) pathway. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-02-21/pdf/2020-03515.pdf?ref=fdaweb.com).