The Institute of Medicine (IOM) has released their latest report regarding their review of the 510K process as requested by the FDA. Recall the FDA requested that the IOM review the 510K process on several specific areas to assess the process with regard to protecting the public health as well as providing innovative devices.
See the attached summary document from the 200+ report as well as the IOM letter to the FDA. In a nutshell, the IOM does not believe the 510K process is effective and a revised process should be developed over the coming years. See the attached for additional information. There is also a webcast of the IOM press conference releasing this report which may be of interest.