FDA cuts 510(k) device backlog by reassigning staff to CDRH

Showdown looms with Republican Congress

The Food and Drug Administration made great strides in reducingits backlog of 510(k) applications in 1994, but its progress maynot save it from a Republican Congress bent on tightening theleash on the agency. Republican legislators now in power, includingHouse Speaker Newt Gingrich (R-GA), have been vocal critics ofthe FDA and several have vowed to revamp its operations to reduceregulatory burdens on U.S. drug and device firms.

By late 1994, the FDA had slashed the number of 510(k) applicationspending for more than 90 days by 75%, from 2000 to about 500.The backlog is expected to continue shrinking until at least thesummer, when it may be reduced to as few as 100 pending applications.

Partly driving this reduction are policy changes that streamlinedthe review process, according to Dr. Bruce Burlington, directorof the Center for Devices and Radiological Health. These includea "refuse to accept" policy for deficient 510(k)s, wherebypoorly prepared applications are not accepted, and assigning applicationsto different levels of review on the basis of potential risk andcomplexity of the devices (SCAN 7/14/93).

The bulk of the reduction, however, was achieved by temporarilyassigning scientists from research laboratories to review backloggedapplications. These workers have now returned to their previoustasks, meaning that the rate of backlog reduction achieved during1994 is not likely to continue, even though additional full-timereview personnel were hired in the last fiscal year.

The purpose of turning bench scientists into reviewers wasto clear the majority of backlogged applications, Burlington said.The strategy is to allow a streamlined FDA review process to keepup with incoming applications. But the review process still lagsbehind its goal of achieving reviews within 90 days. The averagetotal time of 510(k) review is currently about 200 days, Burlingtonsaid.

And the review process remains vulnerable to glitches, as illustratedin October when the government lost its lease on the buildingthat houses the offices where the FDA does its device reviews.The number of 510(k)s in the backlog had dropped to 460 at theend of September, but with more than a week lost in the move tonew offices, the backlog jumped to about 500.

There is no getting around the fact that the number of applicationscontinues to increase and the agency remains understaffed to handlethe growing influx. Furthermore, the improvement in review hasbeen seen only in 510(k) applications, not premarket approvalapplications (PMAs).

"We have put a real focus on the 510(k) program,"Burlington said. "We haven't ignored the PMA program, but(generally) PMAs have not gotten the same level of attention that510(k)s have."

The number of approved PMAs in 1994 was about the same as theyear before, he said. The agency, however, is trying to improveits record with PMAs, stratifying new applications to emphasizethose that appear to have a particularly important medical use,he said. That can work against the quick review of diagnosticimaging devices.

"You need data showing that your product has a major rolein patient care," Burlington said.

That usually applies primarily to therapeutic devices, althoughlast year the FDA granted fast-track review status to ATL's Ultramark9 HDI for use in the differential diagnosis of breast lesions(SCAN 1/19/94). Mammography vendors are also hoping for fast-trackreview for full-field-of-view digital mammography systems. TheATL review is still in process, however, which is not an encouragingsign for other vendors anticipating fast-track review.

The election in November of Republican majorities in both theHouse of Representatives and Senate threatens to turn the entiredevice-reform process upside-down. On one hand, many proposedRepublican initiatives could streamline device review by removingregulatory roadblocks that are driving companies overseas fornew product development and introductions. In addition, the increasedattention to the product-review process may be just the proddingFDA reviewers need to keep their pencils sharp.

On the other hand, the more extreme ideas, such as Gingrich'sproposal to dismantle the FDA and replace it with a private-sectororganization, may force the FDA back into its shell and undo muchof the progress that has been made.

User-fee legislation is another wild card. Capitol Hill observerspredicted another user-fee bill after legislation died last year(SCAN 10/26/94). If another user-fee bill is proposed, however,it will probably be markedly different than the carefully craftedbut doomed compromise reached last year. Sources on Capitol Hillsay that user-fee legislation proposed in this session will likelytarget the money to reducing the deficit, not to increasing theFDA's budget.

The medical device industry can probably look forward to modestgains in PMA review times as well as somereduction in the remainingbacklog of 510(k)s. However, the product review backlog is likelyto increase after the summer, Burlington said.