FDA Letter to Mobile App Developer Signals Regulatory Scheme

Last week, the U.S. Food and Drug Administration (FDA) sent an enforcement letter to a mobile medical app developer for failing to obtain a 510(k) clearance before marketing the app, which the FDA said appears to be a “device” under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA). The mobile app — the uChek Urine Analyzer developed by Biosense Technologies Private Limited and available through the iTunes App store — allows a user to read urine dipsticks using a camera phone to screen for diabetes and urinary tract infections. The FDA’s letter signals the type of oversight the FDA intends to exercise over mobile medical app developers, although the agency has not released final guidance in this murky area.

FDA PREVIOUSLY INDICATED LIGHT REGULATION OF MEDICAL MOBILE APPS -

In March, Congress urged the FDA to clarify the regulation of mobile medical apps in three days of hearings before the House Energy and Commerce Committee. The FDA generally relieved concerns raised by the mobile communications industry, which had feared heavy regulation of mobile phones and tablets as medical devices. Christy Foreman, the Director of the Office of Device Evaluation in the Center for Devices and Radiological Health (CDRH) at the FDA, testified before the committee that the FDA intends to limit regulation to a small subset of apps, in accordance with the FDA’s July 2011 draft guidance on mobile medical apps.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.

Topics:  FDA, FDCA, Healthcare, Medical Devices, Mobile Apps, Telemedicine

Published In: General Business Updates, Communications & Media Updates, Health Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Morrison & Foerster LLP | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »