How the FDA aims to speed review of medical devices
- By Kathleen Hickey
- Mar 09, 2016
The Food and Drug Administration is piloting a new system to speed up the premarket review process for new medical devices.
One of the main bottlenecks in the medical device review process is finding the right expert reviewer. Currently the FDA relies on “the usual suspects” – a core group of reviewers from the FDA Office of Device Evaluation (ODE), according to a GovLab report on the pilot program. However, this pool of experts is limited and may not include those with knowledge of the specific technologies in new medical devices. Finding qualified reviewers outside this core group can take as long as nine months.
To combat the issue, the Department of Health and Human Services is creating a network database of experts -- HHS Profiles -- based on a customized version of the Harvard Profiles Research Networking Software, a National Institutes of Health-funded open source tool for finding researchers with specific areas of expertise.
Potential expert reviewers create profiles in the system describing their skills and experience. The software then imports and analyzes reviewer contact information, publications and other data sources to create and maintain a searchable library of electronic resumes of HHS experts. Representatives of the Office for Device Evaluation can then search the profiles to identify the most qualified individuals to participate in the regulatory review of a given medical device.
The pilot will compare the efficacy of picking expert reviewers from profiles versus the current methods, including determining whether matching individuals based on their published articles and academic degrees is the best method for finding the right reviewer; the time required for the panel to meet and review a device; and safety outcomes – e.g. product recalls and adverse event reports.
The FDA anticipates the new platform will increase the speed and effectiveness of the medical device regulatory review process and expand the pool of reviewers. Currently the premarket approval review process, done exclusively by internal staff, takes an average of 266 days. Reviewing unique devices takes an average of 18 months.
The pilot program is being conducted this year in partnership with GovLab and its MacArthur Foundation Research Network on Opening Governance. Funding is provided by the General Services Administration from its The Great Pitch investment contest.
Kathleen Hickey is a freelance writer for GCN.