The FDA has proposed making it easier to make, market and administer tests for the herpes virus. In a proposed rule released Friday 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. The move to class II from class III would reduce the regulatory burdens associated with herpes tests.That would both lower the barrier to entry for companies seeking to develop and market herpes tests and relax the training requirements for laboratories and medical offices that offer the tests, FDA spokeswoman Julie Zawisza said. That could make the tests both cheaper and more widely available.The FDA considered reclassifying the tests as long ago as 1980, but did not amid concerns about how it could affect the health of newborns. The regulatory agency said the tests posed a “potential unreasonable risk of illness or injury” at the time.
