Focusing on the National Football League’s recent decision to expand a pilot program that encourages team physicians and trainers to use a specially designed downloadable application (App) intended to diagnose concussion and mitigate the risk of long-term permanent injury, this article discusses FDA’s proposed regulation of mobile medical devices and medical Apps as described in its July 2011 “Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications.” The article also provides industry with strategic recommendations for steps that can be taken now when designing and developing similar mobile Apps to expedite and improve the FDA review and approval process. Specifically, industry can:
- Familiarize itself with FDA’s proposed regulatory approach as described in its 2011 Draft Guidance and the included criteria for determining whether a proposed App falls within the scope of FDA’s regulatory authority.
- From the very beginning, design devices and corresponding Apps with the FDA’s proposed regulatory requirements and standards in mind.
- Develop and adopt a regulatory approval strategy early in the development process that possibly includes upfront FDA interaction to avoid future approval obstacles.
- Identify the various performance standards against which testing will likely be required prior to submitting either a 510(k) or PMA to FDA for review; and plan accordingly for the testing to be completed beforehand.
- Pay special attention to data security and data protection if your proposed device involves the wireless transmission of personal patient data to a third-party recipient.
- Seek guidance beforehand on what FDA’s mHealth Product Reviewers are expecting to see upon reviewing a related mobile medical device or App submission.