US FDA is unveiling a new pilot program that will encourage companies to submit 510(k)s electronically with the promise of a quicker review time.
FDA Commissioner Scott Gottlieb unveiled the plan Sept. 5 at the Medical Device Innovation Consortium annual public forum in Washington, DC. "This new approach is like aTurboTaxfor information submitted in 510ks," Gottlieb said at the MDIC meeting. "It will modernize the premarket submission process for medical device by allowing applicants to submit this information to us in a more streamlined and electronic format."
The "Quality in 510(k)" (Quik) pilot employs a structured electronic submissions template (eSubmitter) that allows sponsors to fill in pre-existing data fields required for all 510(k)s, FDA says. This system will enable reviewers to receive the information in a streamlined format to support a more consistent and efficient approach to reviews, according to the agency. FDA says the platform will help reduce the maximum time to make a review decision for most products in the Quik Review program pilot from 90 days to 60 days.
"This is a pilot program, so we will be evaluating the potential for this program to reduce review times, but our expectation is that it may help reduce review times as much as 30%," explained FDA spokeswoman Alison Hunt.
FDA says it will formally launch the pilot Sept. 6, and specified that the pilot would be limited to about 40 product codes that represent moderate-risk devices that are considered by FDA to be well-understood. Eligible product categories will include electronic stethoscopes, surgical wire, and certain cameras used by ophthalmologists.
The pilot builds on years of effort by FDA in constructing more standardized submissions templates and electronic submissions strategies. Initially, the agency experimented with linking electronic submissions with quicker reviews forin vitrodiagnostics, with the 2004-launched "Turbo 510(k)" program and 2012-launched "Triage" program, which sought to achieve a 30-day review time for qualifying IVD 510(k)s.(Also see "US FDA pilot aims for 30-day review of 510(k)s submissions for IVDs, radiology devices" - Medtech Insight, 2 May, 2012.)
Gottlieb said the new pilot will "improve our overall productivity, enabling the agency’s review staff to put more of our time and resources into evaluating applications for devices that pose the highest potential risks to patients."
Years Of Effort
The device center made its first attempt to extend the effort outside of the diagnostics realm with its 2014 eSubmissions pilot. (Also see "TurboTax For 510(k)s? FDA Seeks Volunteers For eSubmissions Pilot" - Medtech Insight, 30 Apr, 2014.) Since then, the agency has worked on improving its structured electronic templates for 510(k)s, as well as other application types, to make electronic submissions more straightforward for sponsors and more useful for reviewers. (Also see "FDA Tries To Get 'Smart' In Standardizing 510(k) Reviews" - Medtech Insight, 4 Nov, 2015.)
The most recent user-fee agreement includes resources and authorities for FDA to eventually require eSubmissions all application types, including 510(k)s, PMAs and more. (Also see "User-Fee Facts: 10 Key Medtech Details From US FDA Agreements" - Medtech Insight, 11 May, 2017.)
Historically, sponsors make paper submissions accompanied by an "eCopy" on a CD or DVD, which has not done much to automate the review process.
From the editors of The Gray Sheet