FDA Regulation of Mobile Medical Applications

In FDA by Bruce A. MacFarlane, Ph.D

On September 25, 2013, FDA issued its final Mobile Medical Applications guidance for industry and FDA staff.   The final guidance is based on the draft guidance issued July 21, 2011, but includes useful additional information.

First, the Agency has added Section V. B., and included Appendix B, which identify types of mobile applications (apps) for which FDA intends to exercise enforcement discretion.  That is, FDA has identified examples of mobile apps that could be regulated as medical devices, but which the Agency has decided not to hold to the requirements of the Food, Drug & Cosmetic Act (the law encompassing medical devices).  FDA has used enforcement discretion periodically over the years in a wide variety of regulatory situations.  Section V. B. and Appendix B provide much a better clarification of the dividing line between FDA-regulated and non-regulated apps than was available in the 2011 draft guidance.

Second, the final guidance includes Appendix F: Frequently Asked Questions with substantive responses to 10 key questions.  Apps developers should take particular note of FDA’s recommendations about software development processes to ensure high quality, ‘bug-free’ apps.

Of course, many apps will fall under FDA’s jurisdiction as regulated medical devices and many of these will require premarket notifications [510(k) submissions] before placing on the US market.

Please contact NAMSA’s regulatory services at 763-287-3830 or at clientcare@namsa.com for support in a) complying with FDA’s expectations for software development, b) assessing whether your app is a medical app and/or requires a 510(k), and c) preparing and submitting any necessary 510(k)s.

Authors:

During his 28 years in the medical device industry, Bruce A. MacFarlane, PhDhas held executive and senior managerial positions in regulatory affairs and quality systems with Bio-Vascular (now Synovis), Vital Images, DiaSorin, and Hypoguard (now ARKRAY USA). In 2006 he joined NAMSA and serves as a Senior Principal Scientist, specializing in FDA regulatory affairs. His regulatory experience includes writing over sixty 510(k) submissions for products such as implantables, electrotherapy devices, surgical instruments, ambulatory ECG devices, esophageal stents, medical imaging software, wound dressings, and in vitro diagnostic instruments and reagents. He has also conducted numerous regulatory assessments of new medical devices and has participated in a dozen pre-IDE (pre-Submission) interactions with FDA. Dr. MacFarlane earned his BA from Yale University; his doctorate from the University of Pennsylvania; and did postgraduate work at The Johns Hopkins University.