Lawyers react to FDA’s recent app guidance activity — or lack thereof

June 10, 2013 in Medical Technology

The Food and Drug Administration’s recent letter to Biosense Technologies regarding an app that can conduct urine analysis has caused healthcare attorneys to sit up and take notice.

The FDA’s May 21 “It has come to our attention” letter is not as serious as an official FDA warning letter, however it is the first letter of its kind in quite some time, says Linda Bentley, a member at the global law firm Mintz Levin and chair of the firm’s FDA practice group.

FDA wrote in the letter that the Biosense uChek Urine analyzer – intended for use with Siemens Multistix SG10, Siemens Multistix SG, Siemens Uristix, Bayer Diastix, and Bayer Keto-Diastix reagent strips – is meant to provide “qualitative and semi-quantitative determination of urine analyses including glucose, urobilinogen, pH, ketone, blood, protein, bilirubin, nitrite, leukocyte, and specific gravity.” 

[See also: FCC, FDA, ONC seek input on health regs.]

FDA asked Biosense to produce a clearance number for the device, or explain why the company feels it doesn’t require one. 

Most attorneys who work in this area would have said the uChek is a Class II device (moderate to high-risk), Bentley says.

“What FDA said in the letter wasn’t surprising,” says Bentley. “FDA didn’t say anything brand new. There was “not much else to glean” from the letter, in a regulatory sense. What is interesting, however, is the timing, she says. The letter came out of the blue. It’s a surprise it came now, and that it was to Biosense, Bentley says. She wonders if Biosense’s recent marketing campaign drew FDA’s attention.

“But for whatever reasons, because it was the first pronouncement from FDA in quite a while –  it made a huge splash in the press. My own feeling is; it was blown out of proportion,” she says.

The last major guidance on mobile devices came in 2011— as a draft. Could the letter to Biosense be a sign that the FDA is waking up and ready to issue the long-awaited final guidance? “We could only hope so,” Bentley says. “There is a lot of desire for it. There are so many products out there.”

Bentley says her legal practice has picked up on mobile apps over the past three months. That may be a reflection of more companies developing new products, plus more concern about doing the right thing, she says.

Matthew Kaminer, general counsel for Epocrates, an athenahealth company, says new guidance from FDA on health apps would be good for the industry. The lack of final guidance since 2011 has had the effect of stifling innovation. “Developers are worried about what apps could be regulated,” he says. “Many are taking the wait-and-see attitude. It would behoove the FDA to get it out as soon as possible.”

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