Policy Changes Shake up FDA Device Review Process

FDA Product Review Backlog is Clearing Up

The medical imaging industry was surprised when the logjam ofmedical device reviews at the Food and Drug Administration brokeearlier this year, but Susan Alpert, director of the FDA's Officeof Device Evaluation, was not. Since she took control of ODE lastJuly, Alpert has implemented several initiatives aimed at speedingup action on submissions while streamlining the flow of new ones.

A major accomplishment has been the development of an expeditedreview process that includes a triage system for bringing high-prioritydevices to the front of the product review queue. Another is arefusal-to-accept policy designed to keep incomplete submissionsfrom clogging the system.

"We have been able to clear groups of 510(k)s by savingour resources for the more complicated submissions that need moreintense scientific review," Alpert said. "Refusing toaccept (inadequately prepared submissions) has also worked verywell for us. The applications that aren't complete are sent backto the sponsor quickly."

Rejected applications are accompanied by a letter explainingwhy they were not accepted and a checklist that tells companieswhat the FDA wants in revised applications, Alpert said.

These and other improvements in the review process have ledto progress in reducing the backlog of imaging device submissions(see chart). Since last fall, the radiology community has welcomeda half-dozen new systems in MRI, ultrasound, nuclear medicineand PACS, as well as an imaging-based neurosurgical tool.

Most medical imaging devices qualify for the less demanding510(k) review process because they or similar devices were onthe market prior to 1976, when the law requiring FDA clearancefor marketing was put into effect. An exception are MRI scanners,which were reclassified several years ago from the more restrictivepremarket approval (PMA) process to the 510(k) when regulatorsdecided that the devices did not pose a threat to the health ofpatients.

Alpert acknowledged that despite recent progress, the battleto get the FDA up to date on device submissions is still far fromwon. Nagging problems continue to delay the process. Instancesof devices that fail to move forward in the queue continue tocrop up. In addition, scientists from the Office of Science andTechnology who were sent temporarily to ODE to help with productreviews will soon return to their regular positions.

There are three common reasons why a product application stalls,according to Alpert: (bullet)a reviewer with the expertise tohandle the application may not be available; (bullet)the reviewerhandling the application leaves the agency or is transferred toanother job; or (bullet)the reviewer is bogged down in other applications.

One of the toughest problems to handle is the frustrationof companies that sought FDA assistance in defining the informationor designing the clinical trial required by the FDA, only to havea different reviewer raise questions about the submission.

"We are doing everything we can to keep that from happening,"Alpert said."But there are going to be individual differencesin the way reviewers do their work."

There are other reasons behind review delays at the FDA. Oneis the increasing sophistication of the submissions coming intothe agency.

"The complexity of what we receive (in submissions) hasincreased and that has had an effect on the information comingin, for the 510(k) process particularly," Alpert said. "Inaddition, we have increased the level of science and the levelof detail we expect to see in 510(k)s. They are more complex andcontain more detailed scientific information than they did fiveor 10 years ago."

The average review time for a 510(k) submission is hoveringaround 200 days, a period Alpert considers unacceptable. Despitethe flurry of new clearances issued, that number stubbornly refusesto drop.

"It's important to recognize that it took several yearsto build the backlog," she said. "It is going to bewith us for some time, but we are trying to reduce its proportions."