The
Biofeedback therapies and the
industry itself has always been regarded as a "black sheep" by the FDA. Could it be that the FDA just doesn’t understand the concept of the biofeedback therapies, or hasn’t taken the time to learn how it actually works. Maybe, is it that the biofeedback therapist and equipment manufacturers have made biofeedback into something other that what it really is, giving the FDA real concern on how it is sold and used. Well, no matter what you want to say about who is actually at fault, biofeedback and the FDA sometimes appear like water and oil, they just don’t mix well. With the present Congressional make up the FDA has been called the friendly FDA to the industry. The FDAMA of 1997 has put the FDA on notice to assure that it looks to reduce regulations on the medical device industry. The FDA has recently lost a court decision on off label information, there is going to be a new Commissioner appointed, the QSR with the Design Review is in full force and the 510(k)
process is also under constant review. What does this all mean to the Biofeedback industry? This
seminar will
provide insight into the present FDA policies on the medical device industry with special emphasis on how it relates to the Biofeedback industry. Also covered will be the biofeedback product labeling requirements, the judgement against the FDA on off label use and the new
guidelines that the FDA has provided on this and the how the new QSR and Design Review should be instituted by the biofeedback
manufacturer. The seminar will also provide insight into the FDA 510(k) review process and the new 510(k) clearance guidelines, and how they can be of benefit to the biofeedback manufacturer. For the biofeedback companies who are marketing or want to market their instruments in the European Community, a review of the CE mark requirements and the ISO standards.