Medtech Attorney Pilot Urges Third Party Device Reviews

Third-party medical device reviews by qualified third-party experts were recommended in 1970 by the Cooper Committee and embraced by the European Union but never enacted into U.S. law. As Pilot explains, such reviews would “reduce CDRH workload and resources; eliminate the need for costly user fees; limit the need for redundant higher pay grade personnel; enable the CDRH to complete PMA review within 180 days; and retain appropriate and efficient use of independent statutory advisory panels.” The Cooper Committee “was emphatic in its belief that external advisory experts were essential to the expected success of the PMA process.”

Today’s advisory panels are a far cry from their forerunners introduced by the 1976 Medical Device Amendments, he argues. They worked well for many years, but “beginning in the 1980s and continuing to today, there have been complaints about the qualifications of the members and FDA management of the advisory panels,” Pilot writes. “These complaints, in part, relate to overly strict application of ‘conflict of interest’ criteria depriving qualified experts from panel membership and possible FDA manipulation of the panels by concealing from PMA applicants information shared with panel members.”