ODE issues annual report
Device Regulation Alert: Safety, Compliance and Reimbursement News, June 30, 2008
The Office of Device Evaluation (ODE) detailed new developments in patient care and medical device technology as well as the FDA’s efforts including new and revised guidance documents and new training for FDA staff in its annual report for fiscal years 2006 and 2007.
The report also highlights ODE’s program initiatives including:
- Preparing for avian influenza
- Evaluating the quality of premarket review memos
- Initiating a pilot program aimed at improving communication between pre and post market teams
- Developing new IT programs to improve efficiency
ODE addressed its own performance in reviewing device-related submissions. The report indicates the turn-around time for reviewing original premarket approvals and panel track PMA supplements has decreased. ODE reports it is also doing well implementing MDUFMA and has met “nearly all of the [MDUFMA] performance goals.”
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