Norman Frederick Estrin, Ph.D. - Comment

The FDA should consider implementation of a system analogous to the OTC Drug Monograph system for class IIa medical devices. Such Monographs would include descriptions, labeling options, performance testing requirements, etc. Predicate devices may no longer be necessary for class IIa devices. In this way, medical devices that meet the parameters set by the FDA for a product type (perhaps as defined by product codes) could be marketed if they meet the monograph without pre-submission requirements or with a simple pre-market notification that the device meets the monograph and will be marketed shortly. If the device has differences from the monograph that could impact safety and effectiveness, supporting data would be submitted with the pre-market notification for expedited review. CDRH could use its guidance documents as a start in developing monographs. These could be prepared with industry input and frequently updated to keep up with innovations in technology. FDA should consider inviting device companies to prepare draft monographs through their trade associations for submission to the FDA. CDRH should study the successes and failures of the OTC Drug program and take all necessary steps to avoid potential problems of inhibition of developing new technologies because of rigid, inflexible monographs, slow progress in developing and finalizing monographs and internal FDA barriers to incorporating innovations in technology into monographs. A final General comment: Much of the 510(k) Working Group report is commendable but it is of much concern that some recommendations, if implemented, could place significant additional paperwork and administrative burdens on the smaller companies of the medical device industry and raise costs sufficiently as to inhibit introduction of new devices. FDA's User Fee authority should not be used for unlimited growth of the FDA at the expense of the industry and patients that would benefit from medical devices.