Chris Pruitt

Subscribe to all posts by Chris Pruitt

FDA Releases Final Mobile Medical Apps Guidance

On Monday, FDA released a final version of its guidance document, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff.    The guidance describes FDA’s approach for regulating certain mobile applications (apps) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Although the final guidance retains the basic framework of … Continue Reading

Lessons from FDA’s First Public Mobile Medical Apps Enforcement Letter

As our colleagues discussed in a previous post on InsideMedicalDevices, FDA took its first publicly announced enforcement action against a mobile app developer on May 22, issuing an “It Has Come to Our Attention Letter” to India-based app developer, Biosense Technologies.  The letter received extensive media coverage, and the mHealth sector was immediately abuzz with interest (and concern) … Continue Reading

FDA Tells Congress to Expect Final Guidance on Mobile Medical Apps This Year

As was reported previously on our sister blog, InsideMedicalDevices, the regulation of mobile medical apps continues to be an issue on Congress’ radar.  Last week, the Republican-led House of Representatives Energy and Commerce Committee held three days of hearings addressing how FDA regulation and the medical device tax could affect innovation in mobile applications and devices, … Continue Reading
LexBlog