FDA POST-MARKET SURVEILLANCE PROJECT
The Food and Drug Administration (FDA) is in discussions with NPA to establish a
collaborative registry project that would provide post-market surveillance services
to the FDA and industry. The Medical Device Epidemiology Network (MDEpiNET) is a
national planning board tasked with evaluating regulatory-grade data sources for the
establishment of a national, and possibly international, coordinated registry network for
medical device studies to identify complications. Established registries, such as those
developed by NPA, provide the potential to enhance post-market device evaluation in a
cost-effective and standardized manner.
The National Institutes of Health (NIH) is discussing a potential registry project to
generate data for un-ruptured intracranial aneurysms through a multi-center registry,
with propensity matching. Other potential projects include studies on brain metastases.
WHAT WE HAVE LEARNED
The NPA focuses its clinical registries on promoting the quality of surgical care and
providing surgeons with the means to assess risk-adjusted measures of the value and
durability of treatment responses. Its registry programs and collaborative efforts assist in
the understanding of patient perspectives on clinical outcomes and provide the ability to
compare the relative effectiveness of various therapeutic interventions.
Clinical data registries have become valuable tools to support evidence development,
performance assessment, comparative effectiveness studies and adoption of new
treatments into routine clinical practice. The NPA remains committed to its efforts to
provide surgeons with the means to demonstrate value and validity in reporting and
improving quality of surgical care through the collection and analysis of outcomes data.