In a proposed rule released Jan. 6 but dated Dec. 21, the Food and Drug Administration said it may change how it classifies tests for herpes simplex virus types 1 and 2, reducing the regulatory burdens associated with the tests. Julie Zawisza, FDA spokesperson, said the change could make the tests easier and more available. The modified policy would lower the entry barrier for companies seeking to develop and market these tests and relax training requirements for labs and medical offices that offer them, she said. As far back as 1980, FDA was considering reclassifying the tests but balked at doing so because of concerns over the health of newborns. At the time, FDA found the tests presented a "potential unreasonable risk of illness or injury." A false positive on an older test could lead to unnecessary treatment with antivirals or unnecessary Caesarean delivery, while a false negative could lead to a potentially fatal herpes infection in the newborn. In explaining its reasoning for proposing the reclassification, FDA said the reliability and performance of the tests have improved in the past 25 years. The agency will accept comments on the proposed change through April 10. For more information, visit www.fda.gov.
Note: I haven't seen the rules, but will try to find a more specific reference for review and comment.