The Food and Drug Administration (FDA) created a stir this week when it sent a letter to app developer Biosense Technologies asking the company why it has not sought clearance for its uChek Urine Analyzer app. It appears that this is the first instance of the FDA taking any sort of regulatory action against a specific mobile medical app in quite some time.
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What’s notable about the letter is not so much the fact that this particular app caught the attention of the FDA. It would be hard to argue that existing medical device regulations should not apply to this app, which assesses glucose, urobilinogen, pH, ketone, blood, protein, bilirubin, nitrite, leukocyte and specific gravity in urine. These functions put the app squarely in the realm of medical devices.
What is really noteworthy here is the fact that the FDA is pushing ahead with regulatory actions even in the absence of finalized regulatory guidance. It has been nearly two years since the FDA issued its draft guidance on mobile medical device regulation. Since that time there has been an explosion in the number and functionality of mobile apps. It’s unclear how much of the original guidance is still relevant to today’s industry.
This is why it is hard to see the FDA taking firm action against any mobile app developer (the letter sent to Biosense is a “It Has Come to Our Attention” letter, which traditionally doesn’t carry as severe consequences as “Notice of Violation” letters with which pharmaceutical companies and clinical researchers are familiar). After all, how can the industry know exactly what’s out of bounds when the main regulatory agency won’t draw the lines?
In the mobile medical device regulation congressional hearings held back in March, Christy Foreman, director of the FDA’s Office of Device Evaluation, said finalized guidance should come before the end of the fiscal year, which ends in September. But pushing off final guidance until then would be too long, particularly given how long it has been since the industry received any form of guidance.
During those hearings, witnesses delivered testimony in which they repeatedly said they aren’t as worried about potential regulatory burden as they are about uncertainty. The Biosense case is a perfect example of the consequences of that uncertainty. In the absence of firm guidance the company developed an app that has some novel functions. Now it is facing regulatory pushback after the fact.
Issuing the final mobile medical device regulations as soon as possible could head off similar problems in the future and rekindle app development from companies waiting for them. In the end, patients will benefit, faster.