If you missed our June 16 webcast of select data from MassDevice's exclusive "Eye on the FDA" report, don't worry: You can download the presentation here.
The 40-minute webcast features MassDevice co-founders Brian Johnson and Brad Perriello, Jodi Raus and Dale Klous of the Regulatory & Clinical Research Institute and Thomas Lee, Minnesota bureau chief for MedCity News.
The webcast dives into some of the data we crunched on the 510(k) program, examining clearance trends in overall decision times and in decision times for various medical disciplines. It looks at the most active disciplines, revealing which are seeking the most third-party reviews and looks at the states with the most active device clusters in terms of 510(k) activity.
The webcast also features a discussion of how potential changes to the system could affect the industry and an update on a recent "town hall" meeting in Minnesota with CDRH head Dr. Jeffrey Shuren.
The full PDF version of our analysis of the FDA's 510(k) clearance process is available below.
This investigation of 2009 510(k) clearances for medical devices by the Food & Drug Administration shows that times to clearance continue to rise, even as the number of clearances granted falls. This report also includes data and analysis of expedited 510(k) clearances and third-party-reviewed clearances during 2009. The report includes a text file containing the details, including names and contact information, for each clearance granted since 1996. The file can be imported into a spreadsheet to create a searchable, sortable index of all 510(k) clearances in the past 14 years.