Originally Published MDDI July 2005
CDRH says fewer than half of the postmarket studies required of the device industry as a condition of approval are completed in the proper time frame. Although industry is not accepting those findings at face value, both FDA and industry agree that the system could be improved, and reforms are forthcoming.
Released in March, the CDRH report evaluated 45 PMAs granted between January 1, 1998, and December 31, 2000, that required postmarket studies. Only 42% of the studies were completed or progressing on time.
CDRH requires postmarket studies as a condition of approval when premarket studies don't tackle lingering safety and effectiveness concerns.
To conduct the evaluation, Office of Device Evaluation (ODE) staff obtained hard copies of postmarket study results from manufacturers. According to the report, 19 of the 45 studies were either on track or finished. However, to get information about the remaining 26 studies, ODE staff had to conduct a survey of lead reviewers of the studies. ODE was able to ascertain that few or no results were available for most of the studies, and no information at all was found for eight studies.
CDRH described industry's performance on this matter as “suboptimal.” AdvaMed, however, wasn't convinced of the accuracy of the report's results, so the group took its own survey. It gathered data from its members cited in the report: 12 companies, responsible for 22 studies. AdvaMed found that either studies were completed or that CDRH had been made aware when studies were cancelled or delayed.
“The characterization of the medical device industry as being substantially out of compliance is both inaccurate and unfair based on the full facts, which were easily obtainable from the sponsors of the cited PMAs,” wrote Jeffrey Secunda in a letter to CDRH director Daniel Schultz. Secunda is AdvaMed's associate vice president of technology and regulatory affairs.
AdvaMed also disagreed with CDRH's statement that unless someone has specific knowledge about a certain device, it's “very difficult” to get information about a study or its status. If CDRH had checked with the study sponsors, “they would have found the appropriate personnel with the necessary ‘extensive knowledge of the ... products under study' to create a more accurate and complete report,” AdvaMed responded.
Despite the contention, AdvaMed agreed that an effective system for tracking postmarket studies is lacking. It also applauded CDRH's actions to improve tracking. These steps include:
• Having the Office of Surveillance and Biometrics track, design, and evaluate postmarket studies instead of ODE. ODE will continue to track device safety and effectiveness after market release.
• Implementing an electronic tracking system to help CDRH formally monitor the status of condition-of-approval (COA) studies. If a
report is overdue, the company will be contacted.
• Hiring three epidemiologists to work with ODE and medical device manufacturers on the design of COA studies earlier in the PMA review process.
• CDRH reporting postmarket study results to its advisory panels.
CDRH also plans to publish a draft guidance for industry and FDA reviewers. The guidance will establish rules for the content, format, and due dates of postmarket studies. CDRH may use its Web site to post status reports on the studies.
The complete report is available online at www.fda.gov/oc/whitepapers/epi_rep.pdf.
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