Devices

Support for Reclassifying HIV Tests

Stakeholders say they support an FDA proposal to reclassify human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and human immunodeficiency virus nucleic acid diagnostic and supplemental tests from Class 3 to Class 2 with special controls. The Association of Public Health Laboratories says the change will “achieve urgently needed improved accessibility to the latest HIV testing technology in the U.S. to improve patient diagnosis, laboratory efficiency, patient management, and public health surveillance. The association says it is concerned about the continued omission of quantitative nucleic acid tests for HIV monitoring and the stringent special controls for clinical sensitivity or clinical specificity.

In its comment, OraSure Technologies says it supports the FDA proposal to down-classify professional use HIV serologic and nucleic acid tests and strongly believes the special controls that have been specified should be included to ensure that HIV tests continue to meet critical standards for quality and safety. “Multiple test developers and manufacturers have met these performance criteria in the past which is why, in general, the reported performance of HIV tests continues to be at the highest levels of any diagnostic test on the market,” the company writes.

Abbott says it supports the FDA recommendation and asks the agency to clarify in the final order that the special control to submit a complaint log for five years following clearance of a traditional 510(k) does not apply to currently marketed PMA devices subject to the proposed order because the agency has reviewed manufacturing information as part of the PMA, conducted pre-approval inspections as appropriate, and received annual or periodic reports for the devices.

Hologic says it supports the reclassification and points out that the reclassification of HIV viral load tests is not included in the docket’s scope. “There is sufficient understanding about the risks of viral load tests to support inclusion of viral load testing as part of this reclassification,” it says. “The risks associated with diagnostic testing are substantially higher than for viral load testing.” The company also identifies two special controls mitigation measures that it says appear redundant or unnecessary.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome