As most medical imaging vendors can attest, delays in the processingof 510(k) applications are long and growing longer. More fundssupporting the review of applications can help but not solve theproblem. Delays can be trimmed substantially, however, if
As most medical imaging vendors can attest, delays in the processingof 510(k) applications are long and growing longer. More fundssupporting the review of applications can help but not solve theproblem. Delays can be trimmed substantially, however, if governmentreviewers spend less time chasing data that should have been includedin the original application, said Bruce Burlington, new directorof the Center for Devices and Radiological Health of the Foodand Drug Administration.
The FDA will make an effort to identify deficient 510(k) applicationsas they come in and send them back to the applicant for reworking.This process will increase agency efficiency and reduce delaysfor applicants with both adequate and inadequate clinical trialdata, Burlington said. Previously, applications could pile upfor 90 days, after which there might ensue a two-week scrambleto review and patch deficient ones.
Burlington discussed plans to improve the 510(k) review processin an interview supplied to SCAN by the Tech Assessment Imagingnewsletter.
"We will be instituting a stringent review-to-file policy.If there are 510(k)s coming in that are administratively incomplete,we are going to send them right back," he said. "Ifthere are some that don't come close to the mark for quality ofpresentation--if they are grossly deficient--we are also goingto send them back after a fairly quick preliminary look."
CDRH is also taking steps to increase the number of staff physiciansassisting the Office of Device Evaluation, Burlington said.
"Cumulatively, we have provided approximately 24 new physiciansto help the ODE do its job. Since that represents more than 80%of (all review physicians) we have, I think it shows a clear commitmentto providing the resources to get ODE functioning," he said.
But the task of taming the 510(k) process is getting harderall the time. Rather than just pour resources into solving theproblem, CDRH hopes to make the review process more rational byproviding clearer guidelines and better planning. Ultimately,this should reduce costs for applicants and the agency.
"There are simply more (applications) coming in than weare able to process and send out. This must be tremendously frustratingfor manufacturers," Burlington said. "We need to getthat backlog down so that we are ready to begin the review ofapplications very soon after receipt. That will be the biggestsingle factor in (providing) more timely decisions."
Not only is the quantity of 510(k) applications rising, butthe complexity of many submittals is increasing as well. The agencyhas not been able to spend more time with these individual applicationsdespite their increased complexity, according to Burlington.
One way to provide more resources for review is to expand thetypes of applications that are exempt from review.
"If the public risk is very small, then we should be savingthe resources we have to look at the products where public riskis larger," Burlington said.