What last minute changes to FDA rules are you referring to? Sounds like your are implying that the FDA is in bed with big pharma. I don't doubt that the "big boys" are worried about this type of drug free pain relief (PEMF) catching on, and that their market share might be in danger, however unless they have some FDA officials on the pay role, the BIEL patch will get an impartial review and most likely will get approved. I don't see how the FDA could not grant approval to BIEL for the Allay patch. In order for BIEL to have obtained their current 510K approval from the FDA they would have had to already prove the efficacy and safety of the patch. The Allay patch is just a modification of the Actipatch and fails within the meaning and intent of 510K approval.
Premarket Notification is used to obtain marketing clearance for a device that is “substantially equivalent” in safety and effectiveness to another lawfully marketed device or to a standard recognized by the FDA when used for the same intended purpose(s). Note that the concept allows for technological advancement; the new device does not HAVE to be manufactured from the same materials or perform its intended purpose using the same technology. In order to be eligible for 510(k) clearance, the new device must exhibit roughly the same safety and effectiveness characteristics as the “predicate” device to which the new one is being compared.
Based on the purpose and intent of 510K clearance, FDA approval should be granted for PMS use, and should be a slam dunk for many other uses. From what I've read the Ally patch meets all the necessary criteria. I Don't see how any FDA offical could argue against it, unless that person is being paid to do so.
