2004N-0527 Medical Devices; Medical Device Reporting
FDA Comment Number : EC4
Submitter : Mr. David Parks Date & Time: 05/26/2005 11:05:26
Organization : Alegent Health
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
There is no reiteration of & clarification on the definition of "medical device." This appears to be a major oversight. I think this would be an extremely valuable and critical addition to the new "plain language" regs.