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510(k)s pose PR puzzle for vendors


Imagine if you will: Your company spends hundreds of thousandsof dollars and several years developing a product sure to be thehottest thing in medical imaging since the invention of MRI. Youjump through all the regulatory hoops and wait the standard

Imagine if you will: Your company spends hundreds of thousandsof dollars and several years developing a product sure to be thehottest thing in medical imaging since the invention of MRI. Youjump through all the regulatory hoops and wait the standard 90-plusdays to get a thumbs-up from the Food and Drug Administration.

That day finally arrives, and you want to tell the world thegood news. Why not send out a press release saying the governmenthas approved your product? Not so fast, says the FDA.

The issue of what is and is not permitted when discussing FDAaction on 510(k) applications has long bedeviled the medical imagingindustry. The agency has been especially touchy since the appointmentof commissioner David A. Kessler, who brings a penchant for enforcementto the agency's operations.

Most new medical imaging devices and device upgrades go throughthe 510(k) process, in which the FDA clears products for marketbased on the determination that they are sufficiently similarto other products already in commercial distribution. Applicationsfor 510(k)s are less scientifically rigorous than premarket approvalapplications (PMAs) or new drug applications (NDAs).

The agency is concerned about the notion that successful negotiationof the 510(k) process implies that a product has been endorsedby the federal government. Particularly verboten is the word "approved,"which suggests such an endorsement, according to Steve Niedelman,deputy director of the FDA's Division of Compliance Operations.

"We try to shy away from the word "approved"whenever possible," Niedelman said. "We don't want anyfalse impressions that the FDA has approved, condoned, or endorseda product."

An informal survey of press releases on FDA 510(k) actionsfinds a number of companies using the A-word. Those companiescould find an FDA warning letter in their mailboxes if the agencycatches on, Niedelman said.

WHAT CAN COMPANIES SAY about the 510(k) status of their productwithout stepping on regulatory toes? One company's experienceindicates that the rules are so confusing that even the FDA ishaving trouble keeping track of them.

Evergreen Technologies of Gaithersburg, MD, received FDA 510(k)marketing clearance this year for its MedVision Viewer, a softwareproduct that allows remote image viewing on Apple Macintosh andPC/Windows computer platforms.

Evergreen contacted the FDA's Office of Labeling Complianceto find out what it could say about the FDA's action on its 510(k).

"They said it was against the law to put anything in writingsaying we had cleared 510(k)," said Karen Siegel, Evergreenmarketing director. "They said you can tell customers verbally,but you can't put it in writing."

According to Niedelman, however, written mention of 510(k)clearance is acceptable as long as it is handled correctly. Mentionof the FDA action in a press release sent to the news media islegitimate. But any mention of 510(k) clearance in promotionalliterature sent to customers violates federal regulation 21 CFR807.97 and is prohibited, Niedelman said.

"To say that the agency cleared a product for marketingtoday, that's a press release, that's okay," Niedelman said."But if you're going to promote your product as if it wereFDA-approved, that connotes that the 510(k) process is an approvalprocess."

There are some gray areas, however. For example, a companywould be violating regulations if it mentioned 510(k) clearancein a press release that was subsequently distributed to potentialequipment purchasers at a conference.

"A press release is sort of a fine line," Niedelmansaid. "If it states that the agency has cleared a productfor marketing today, I don't see where the problem is. When itbecomes promotional material, it's a different story."

And mentioning "approved" is unacceptable in anycontext, Niedelman said.

The situation may be cleared up in the near future, althoughperhaps not in the manner device manufacturers would prefer. TheFDA is considering new advertising and promotion guidelines toaccompany stricter device regulations that are being drafted,Niedelman said.

Evergreen eventually put out a press release about MedVisionthat stated that the product has completed all testing, but madeno mention of its FDA 510(k) status, according to Siegel.

The most frustrating aspect of the experience is that manyof the company's competitors have not even applied for FDA 510(k)clearance for similar software products, Siegel said.

"I have seen products that are being shipped that don'thave clearance," Siegel said. "We had to hold back aproduct three months (to get FDA clearance). We obeyed the rules.Shouldn't we be able to say that we have clearance?"

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