Is VAX-D experimental or investigational?
Most definitely No. The FDA is the only agency that can make a decision whether a product ( device or drug) is experimental . No one else has that authority. Devices that have been registered by issuance of a 510(K) are not experimental and require no further investigation or testing as long as the use of said product is consistent with the official usage and/or indications. VAX-D was issued a 510 (K) in 1996. Therefore, it is not experimental or investigational.
