The Food and Drug Administration seeks to speed up the review of medical devices with a new pre-market pilot program.
How does the FDA handle pre-market approval now?
The FDA uses a group of reviewers from the Office of Device Evaluation (ODE), and the main issue with that is that the pool is populated by a core group of experts, thus decreasing the amount of medical devices that can be reviewed and creating a regulatory bottleneck. Another issue, is that with transforming technology, experts are unfamiliar with uncharted territory. What is the resolution? The FDA wants to branch out and bring in more experts – but the search could take up to nine months.
The LinkedIn of FDA Experts
The Department of Health and Human Services has gotten creative! They have plans in the works to create a database of experts derived from a customized Harvard Profiles Research Networking Software. It’s an open source tool funded by the National Institute of Health that sets up a network of researchers with highly specific – and even niche – expertise.
Think of it as a LinkedIn for experts, they create a profile with their skills and experience. When a new profile is made, the system analyzes it and places the profile in a vast bank of searchable experts. These virtual resumes are pulled and vetted when a new expert is needed in a certain area. The most qualified experts are added to a regulatory review for a medical device.
Changing Old Methods
Currently experts are identified when searching through published articles and studies. They review the author’s credentials and are invited to perform a risk assessment review of a medical device. But it is an inefficient process according to the FDA.
The FDA aims to speed up the process by expanding their pool of experts. On average, the approval process takes about an average of 266 days, if it is a niche device, it could run as long as 18 months. This quicker review process will be conducive to medical device makers getting to market faster and allows for faster innovation for new devices.
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