FDA Device Clearance Process

  • On May 14, 2014 at 09:05AM
  • Categorized in Conferences

Companies seeking medical device market approval and clearance often encounter roadblocks when it comes to submissions. This program addresses FDA approval processes, including the framework of the 510(k) and de novo programs, how to go to market with general intended use and specific use statements, how to select the correct predicate choice, how to approach the FDA if issues arise, company experiences with the FDA, and the future outlook of medical device approval in the United States.

Helping clients be appropriately aggressive, yet compliant. TM