I also agree with your comments on the balance of speed and safety in the 510(k) review process. I believe there may be some risk when a device is cleared primarily due to its similarity to an existing predicate device which may have been developed under limitations that were unknown at the time of development. However, I believe 510(k) as a whole is not unsafe as companies will need to test their products and comply with post market monitoring requirements.
The real question is whether FDA is judging substantial equivalence enough and if the new device sufficiently differentiates itself from the predicate. For devices that have only slight modifications, less clinical evidence may be acceptable. However for those that introduce new technologies, this may create uncertainty regarding the product's safety and performance. Do you believe that restricting the use of predicate devices would assist in protecting patients without slowing the 510(k) review process?