FDA issued a proposed rule that would encourage the development of a type of test used to detect cases of tuberculosis (TB). This rule would lower the current risk classification for nucleic acid-based tests allowing IVD manufacturers to utilize the faster, more streamlined clearance pathway for medical devices.
Currently, these tests are Class III (high-risk) devices that require the more rigorous premarket approval (PMA) application. In proposing to downclassify to Class II (moderate-risk), FDA also issued a draft guidance for IVD manufacturers that identifies the risks associated with false positive and false negative test results, the risks to healthcare workers handling specimens, and makes recommendations on how to mitigate those risks.
“FDA has assessed the risk and benefits of nucleic acid-based diagnostics for TB and believes that we can continue to address their safety and effectiveness through our draft guidance,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety in FDA’s Center for Devices and Radiological Health. “Taken together, these actions will encourage the development of new TB diagnostics while continuing to assure their safety and effectiveness.”
CDC recommends healthcare providers perform nucleic acid testing on at least one sample of mucus coughed up from the lower airways (sputum) from patients with signs and symptoms of TB disease, when the test result would alter patient treatment or TB control activities.
“Improving access to promising new TB tests is critical to advancing TB prevention efforts. New tools for diagnosis and greater emphasis on tools that will help identify drug resistance are essential for eliminating TB in the United States,” said Kenneth G. Castro, M.D., director, CDC’s Division of Tuberculosis Elimination.
FDA is seeking public input on the draft guidance for 90 days. Comments can be submitted online or in writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.