FDA revises policy for 510(k) device displays

Device manufacturers are waiting on pins and needles for the Foodand Drug Administration to release its new policy on trade showexhibits of investigational devices. Uncertainty over the newrules has not dampened enthusiasm for the upcoming RadiologicalSociety of North America meeting, however.

The FDA ruffled more than a few feathers earlier this yearwhen it proposed the banning of investigational device exhibitsfrom trade shows. The proposal is part of an aggressive FDA campaignto crack down on illegal promotional activities by manufacturers.

The flap over device promotion and advertising began when theFDA started investigating complaints from industry about illegalactivities. The agency, which was already rewriting standardsfor industry-sponsored CME programs, announced its intent in Februaryto ban exhibits of devices that are pending 510(k) clearance.

Representatives from the Health Industry Manufacturers Association(HIMA) and the National Electrical Manufacturers Association (NEMA)have met with FDA officials to forge a compromise rule.

Banning investigational devices from display is like throwingthe baby out with the bath water, said Maureen Tandy, senior analystand counsel for HIMA.

"There is an important interchange at these meetings betweenmanufacturers and physicians," Tandy said. "Companiescan show their products and get ideas from physicians about theirdesigns. It also serves an educational function."

More importantly, manufacturers need to get their devices-in-progressout in front of hospital administrators who plan future capitalequipment purchases.

"Hospitals need to be introduced to the coming technology,"she said. "The exhibit gives manufacturers a chance to showcasetheir state-of-the-art. But they can't promote those productsfor any uses that aren't approved, or take sales orders--that'sclear under the existing policy."

The FDA has backed off on a total ban, according to StevenNiedelman, director of compliance for the Center for Devices andRadiological Health. But the agency is developing a new policythat will limit types of promotional activities for products notcleared for marketing.

THE SHIFTING SANDS OF FDA POLICY have not affected would-be RSNAexhibitors, however, according to Mike O'Connell, director ofexhibits for the RSNA. He predicted a record-breaking number ofcompanies displaying devices at this year's event.

The FDA will be out in force at the RSNA meeting, but thatis not unusual. Agency representatives usually attend the annualevent, he said.

"I don't think it's any sort of police effort," hesaid. "They will be there as interested parties in the fieldof radiology and medical devices. But there has been concern thatif the FDA is at the meeting it might mean something bad. It doesn'tmean anything."

O'Connell has already fielded a dozen or so calls from manufacturersabout RSNA policy vis a vis increased FDA scrutiny. But sincethe RSNA already requires exhibitors to abide by state and federallaws regulating devices, no policy changes are necessary, he said.

"We haven't received any indication from the FDA thatthere will be a negative impact on display or discussion of unapproveddevices at the RSNA meeting, so long as discussions comply withexisting FDA regulations," he said.

At a HIMA seminar on marketing held this summer, Niedelmansuggested that exhibitors take a simple test to determine whetherthey are staying within the rules of the FDA.

"If your promotional activities are not factual, are notclear, do not tell the whole truth, or may be misleading, youneed to look closely at them and make changes," he said."Be aware of how your product may be promoted by others.Listen to your conscience and common sense to avoid costly andembarrassing mistakes."

Even if the FDA changes its current policy just prior to theRSNA meeting, O'Connell does not anticipate any substantial changes.

"It may be that manufacturers will have to be more obviousin their labeling of devices as investigational," he said."Beyond that, we don't see any restrictions on the usualmarketing activities conducted at the meeting."