MMA Roadshow: Managing App Development Under FDA Regulation
The Media Lab E14 Building is found on the eastern edge of the MIT Campus. It is in close proximity to Kendall Square, Memorial Drive, and the Longfellow Bridge.
By T subway:
Take the red line to the Kendall/MIT stop, follow Main St. west to Ames St., turn left, walk the distance of about one block to the cross walk and the Media Lab Building will be on your left. The E14 entrance will be at the end of the building on the corner of Ames and Amherst.
Coming across the Longfellow Bridge or from Memorial Drive, follow signs for Kendall Square. Limited metered parking is available on Ames Street. There are pay public parking lots near the MIT campus, the Marriott Parking Garage being close to Kendall Square.
Here is a link to the public parking lots in the area … http://web.mit.edu/facilities/transportation/parking/visitors/public_parking.html
Thursday, March 20, 2014
8:00 a.m. - 12:30 p.m.
FDA recently published its final guidance on mobile medical apps, and while helpful, the guidance leads to more questions. This workshop will focus on answering those questions for app developers in or close to FDA regulated territory. Over the course of four hours, we will dive deeply into the regulatory issues associated with bringing new mobile apps into the healthcare space, to help both the novice and experienced FDA regulatory professional alike.
In the MMA Roadshow, we will examine topics such as:
- 1.) How to develop mobile apps that come as close to the FDA line as possible, but don’t cross over into regulated territory.
- 2.) For those apps that FDA does regulate, how to figure out the appropriate classification in a system that frankly hasn’t been updated in a long time.
- 3.) If your app requires premarket clearance, what predicates are available and more importantly what strategies are there for showing substantial equivalence.
- 4.) Practical steps for developing an FDA quality system that is nuanced to fit mobile apps, and is designed to be as economical as possible.
- 5.) In a global economy, what are the differences between the US regulatory system and the EU system, and how can a company efficiently enter both markets?
- 6.) From the perspective of seasoned executives, what are the management challenges you can anticipate in mobile app development in a regulated environment?
The program will be of interest to all levels of experience, from those just thinking about developing an app to those experienced in medical device and mHealth regulatory affairs.