Deanna J Carter - Comment

A delineation between class II devices to include "IIa" and "IIb" to aide in determining which devices require clinical data to support a 510k will be extremely value added. Will devices that are IIb (presumably requiring clinical data) be required to have clinical data if the predicate device was approved under the new "IIb" class? In other words, if the predicate device provided addt'l clinical data, would the new device be required to submit even more clinical data? Clarification around those requirements would be appreciated. Schematics, pictures, devices, or visits to the device (in case of large devices), should be employed. However, zero of this data should be available to the public. However, if this is implemented, it seems reasonable to expect FDA to require this of everyone, not just those companies that can easily transport a device. In other words, just because a visit to the company may be required, this should not remove or lessen the requirement of seeing a device. Either devices are required or they are not. Clear guidance on expectaions / requirements of the 510k submission would be highly value added. Periodic reviews of the 510k cleared devices is something that should be employed. Perhaps this is something that is performed during a Mfg's audit. The examples in the report aided greatly in conveying key concepts. Examples such as these should be employed more often in FDA's guidance. FDA guidance is sometimes perceived as being law to some reviewers and industry. Tighter controls need to be implemented to streamline this thought into either they are requirements or they are not. The"c" in cGMP can be misleading and fear inspiring. One cannot know what one does not know. If FDA reviewers do not have a clear understanding of what the requirements are and what the requirements ought to be, the MFG is left in the dark. Guidances need to be made law if FDA is going to expect them to be implemented.