U.S. medical device regulators are looking for volunteers to test out a software-based version of its 510(k) submission program, an alternative to submissions that traditionally require paper copies or compact discs.
The new "CDRH 510(k) eSubmissions Pilot Program" will guide users through creating and submitting a 510(k) medical device review application electronically. The FDA is hoping a few guinea pigs will volunteer to run the course and provide feedback.
The agency is looking initially for companies submitting products to the Cardiovascular Devices Cardiac Diagnostic Devices Branch or Peripheral Interventional Devices Branch, but all types of device makers are invited to check out the software and comment, according to an FDA memo.
"We encourage 510(k) sponsors of all device types, including those reviewed in other branches, to review the user interface and provide feedback via the Federal Register docket," the agency said. "We will evaluate participation in the pilot to determine the need to expand to include other device types."
The e-submission guinea pigs must contact the pilot program team to signal their intent and then download the eSubmission software. Users will get an account and both public and private keys for signing documents electronically. The program will help the user create a personalized submission package to send to the FDA for review.
The eSubmissions pioneers will get to avoid Refuse to Accept review, allowing them to head straight to more thorough examination, the FDA said. The program also aims to guide users away from common pitfalls and omissions that can tie up review and delay decisions. Ultimately the FDA hopes that the software will help cut down on the time industry spends building submissions as well as the time the agency spends vetting them.
The initial pilot program will only last a few months, with new submissions accepted until Sept. 30, 2014. The program may remain open longer "as resources and the CDRH 510(k) eSubmissions Pilot needs allow," the FDA said. The agency plans to take a total of 50-100 applications, and may opt to limit the number of applications from an individual manufacturer if the program’s overwhelmed with requests.
If the pilot is successful, the FDA plans to explore additional e-submission options, including third-party software or manufacturer-produced programs for producing 510(k) applications.
"Submissions will require fewer resources devoted to processing the submission for review," the FDA said. "Reviews will be easier and faster due to a standardized submission structure."