The FDA’s Triage pilot program, which ended in October 2012, has been deemed a success by the agency. So much so that it is now integrated into the agency’s approval process, says Don St. Pierre, Deputy Director for New Product Evaluation, Office of In Vitro Diagnostic Device Evaluation, at CDRH. He will present results of the six-month program at MD&M West in Anaheim, CA, on Monday, Feb. 11.
Conceived as an internal workload management tool, the Triage pilot allowed good-quality submissions that met a set of criteria to be cleared within 30 days or less. Traditional and abbreviated 510(k)s qualified for the program, and “about 10% of eligible submissions that entered into the office were put in the quick review program, which was in line with our projections,” says St. Pierre. Agency staff appreciated the reduction in their review burden, leaving them more time to devote to complicated submissions, he adds, and industry feedback has been positive. The process has now been integrated into the agency’s approval workflow. On the heels of that, FDA’s Office of Device Evaluation (ODE) is considering launching a pilot of its own. “ODE is looking at our assessment and figuring out how it might work for them,” says St. Pierre.
At the conference, St. Pierre also plans to address the Refuse to Accept (RTA) Policy for 510(k) guidance document, which the agency implemented at the beginning of 2013. The results are not quite as stellar, but it is in its early days and the program does have a learning curve, says St. Pierre.
The need for guidance emerged during discussions on the Medical Device User Fee Amendments (MDUFA) in 2012. “The quality of submissions was declining, and it was decided to address that by developing objective criteria that industry could follow, and refuse to accept submissions that did not meet those criteria,” says St. Pierre. Companies should not be failing the RTA, but clearly they are, he says. His advice is to obey the checklist that is appended to the guidance. “My recommendation to IVD companies is to include the checklist and say where things are in the submission so they can be found.” Are there any doubts that this will spark a lively discussion in Anaheim?
On the subject of RTAs, a recent article by industry consultant Dennis Rubenacker of Noblitt & Rueland asserted that FDA reviewers were following the guidance before its publication on Dec. 31, 2012, causing an additional regulatory burden on industry. I asked St. Pierre about this, who responded that staff were being trained on applying guidance while it was in draft form, but that all submissions were accepted during that time. “Nothing should have been [classified] 'refuse to accept' in 2012,” he says. “Staff were trained on it, but in the tracking system they coded the submission to say that it would have failed had the guidance been implemented. Since that was not the case, it did not get an RTA. If anybody got a refuse-to-accept in 2012, they should complain,” says St. Pierre.
You have a golden opportunity to do just that, and catch up on regulatory developments in the process, at MDM West in Anaheim, CA, USA. St. Pierre will be speaking on Monday, Feb. 11, as part of the conference program’s regulatory submission and approval track. Full information is available at www.mdmwest.com.