Regulatory Focus™ > News Articles > FDA Proposes Lowering Risk Classification for Devices Used to Detect Tuberculosis

FDA Proposes Lowering Risk Classification for Devices Used to Detect Tuberculosis

Posted 16 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is calling for the reclassification of devices used to detect cases of tuberculosis (TB), lowering the current risk classification in a move that it hopes will streamline the clearance pathway for medical devices.

"Currently, these tests are Class III (high-risk) devices that require the more rigorous pre-market approval application," said FDA in a statement released on their website 16 March 2012.

FDA is proposing to downclassify the devices to a Class II (moderate-risk) classification, and released a draft guidance document to assist industry.

"Taken together, these actions will encourage the development of new TB diagnostics while continuing to assure their safety and effectiveness," said Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA's Center for Devices and Radiological Health. 


Read more:

FDA Press Release - FDA proposes lower risk classification for certain tuberculosis tests

Federal Register - Draft Guidance for Industry and Staff; Availability: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens

Microbiology Devices: Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis Complex

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