A new early-stage pilot program quietly under development by the US Food and Drug Administration (FDA) hopes to make it easier for medical device companies to see how their device is progressing through the agency's regulatory processes, all at a glance.
CDRH Submission Tracker Pilot
The Center for Devices and Radiological Health's (CDRH) pilot program, known as the CDRH Submission Tracker pilot, is an attempt to allow companies large and small to have a better sense of how their application is progressing through FDA, explained Nels Anderson, a biomedical engineer within FDA's Vascular Surgery Device branch.
"We are in the initial stages of designing a website-based portal that would allow sponsors to check on the status of their 510(k) submissions that are under review by the FDA," Anderson explained in an interview with Regulatory Focus.
According to current mockups of the portal, each 510(k) submission would be given a website where submitters could track the overall progress of the device as it progressed through FDA's review process.
The current mockup—which Anderson emphasized was preliminary—includes an overview of the device, the FDA staff reviewing the device and their contact information, the status of the submission and the dates at which the device passed key review milestones, the current status of FDA's "review clock" under the Medical Device User Fee Act's (MDUFA) metrics, and (if applicable) the number of days an application has been with a sponsor (e.g. if FDA requests additional information).
A 'High Value' Target
Anderson explained that the idea, which is being spearheaded by CDRH Director Jeffery Shuren, came out of the MDUFA negotiation process. While members of the medical device industry were supportive of the idea of a submission tracking portal, Nelson said, neither they nor FDA had resources available for the project at the time.
But thanks to the SalesForce platform, FDA was able to build the pilot program relatively easily and cheaply since it didn't have to hire contractors to build the program from scratch, Anderson recounted.
The program, Anderson said, represented a "high value" target that should be enormously useful for members of industry, who are already working with FDA to build the program. Nelson said industry trade groups AdvaMed, MITA and MDMA have all been providing input to the agency on the program, which remains in what Anderson called its "planning stages."
Seeking Small Companies
But now FDA is looking to begin ramping up the pilot program, and is looking for some help from outside entities.
"We're looking for three small companies that are willing to work with us on that project," Anderson said. "While we have a number of large corporations working on this with us, we know that smaller companies will have different needs and a different take on the information and we want to make sure they are included in this process."
The input the agency obtains will then be used to create a larger pilot program, the release date of which is still up in the air. While the original intent was to pair the pilot program up with another pilot, FDA's 510(k) eSubmissions pilot program, the two have been de-linked due to different rates of progress.
Anderson indicated that interested companies can email him for additional details.