Mobile Medical App Guidance & Beyond! Keeping Up with Technology, Enforcement Headaches, and Still More FDA Guidance
In July, 2011, FDA’s Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research, which is responsible for regulating medical devices, issued DRAFT guidance for mobile medical applications. The mobile industry as well as the medical device and drug industries have commented on the draft guidance and are anxiously awaiting the final guidance. The nearly 2-year delay may have been part of the reason for the recent House Subcommittee on Oversight and Investigations hearing regarding “Health Information Technologies: Administration Perspectives on Innovation and Regulation.”
Many experts and industry representatives testified at these hearings, including Bradley Merrill Thompson, Member of the Firm at Epstein Becker & Green and General Counsel to the mHealth Regulatory Coalition. Thompson was also interviewed by Pharma Marketing News.
This article is a review of Thompson’s testimony and interview. It covers the prospects for FDA’s final guidance on regulation of MMAs and other regulatory issues that the mobile health community and FDA will likely face after publication of the “final” guidelines.
Topics include:
- Draft MMA Guidance
- FDA Addresses Fears of Over Regulation
- The FDA Director Man Who Cried “Soon!”
- Keeping Up with Technology
- Taxing Innovation
- Don’t Pee on Your Smartphone – Keep FDA
- Après La Guidance, Le Déluge
- The Cheerios Lesson
- Patient Groups Not Being Heard
- Small Enterprises, Big Problems
- Enforcement Issues
- Other Mobile Guidance of Concern to Pharma
Download the full text PDF file here:
http://ec2-54-175-84-28.compute-1.amazonaws.com/pharma-mkting.com/news/pmnews1204-article01.pdf
PMN1204-01
Issue: Vol. 12, No. 4.1: 17 April 2013
