Originally Published MDDI February 2005
MDUFMA reforms have improved the modular premarket approval (PMA) application system, but there is still a long way to go. Speaking at November's MDUFMA stakeholders meeting, an FDA official said industry can choose between shorter review times and more predictability. Two revisions to CDRH's modular PMA guidance already have resulted from industry input, added Office of Device Evaluation reviewer Thinh Nguyen.
First, he said, panel-track supplements, even those with clinical data, can be submitted as modular PMAs. “You cannot divide the clinical data, but you can submit the preclinical data as a module,” he said.
Second, an applicant may now submit two modules at the same time if the review team allows it. “We can handle that now because PMA teams are bigger” as a result of new hires enabled by MDUFMA, he explained.
The number of modules per modular PMA has been decreasing as a result of the guidance document, he said. However, he noted, that has not yet translated into faster review times. Modules that have been submitted recently are more complex than before. They are also more likely to include challenging information such as preclinical and biocompatibility data. “That means there is wide variability in the number of review days, and review times are unpredictable,” he said. “They can be 30 days, or 400 to 500 days.” Indeed, after a drop in average review time per modular PMA cycle each year between FY 2000 and FY 2002, review time increased in FY 2003. At the time of the meeting, FY 2004 data were not complete.
Hence the two choices ODE is proposing to industry for FY 2006 and FY 2007. The first would offer more predictability but longer average review times. ODE would aim to act within 120 days on 70% of modules received in FY 2006 and on 80% of those received in FY 2007. The second option would offer shorter average review times but less predictability, Nguyen said. The goal would be to act within 90 days on 50% of modules received in FY 2006 and on 60% of those received in FY 2007.
Nguyen invited industry to submit comments and suggestions on the matter to the MDUFMA docket. Information on how to submit to the docket can be found at www.fda.gov/cdrh/mdufma/mdufmadocket.html.
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