MRC Comments on FDSIA Report
MRC comments on the Food and Drug Administration Safety and Innovation Act (FDASIA) Health IT Report: Proposed Risk Based Regulatory Framework (the “FDASIA Report”).
MRC FDASIA Comments (July 3, 2014)
MRC Accessory Policy White Paper
MRC Accessory Policy White Paper (July 3, 2014)
“The MMA Roadshow”
Managing mHealth App Development Under FDA Regulation
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.
We have selected some of the world’s leading engineering universities – in the US and in the EU – to be our partners in this program. We have sought out not only the best schools, but those located in population centers near where developers are working.
We will dive deeply into the regulatory issues associated with bringing new mobile apps into the healthcare space.
Locations include:
- University of Illinois at Chicago
- Johns Hopkins University
- University of California San Diego
- Stanford University
- University of Texas at Austin
- Massachusetts Institute of Technology (MIT)
- mHealth Europe Summit (Berlin, Germany)
Agenda
Over the course of a four hour program, we will examine topics such as:
- How to develop mobile apps that come as close to the FDA line as possible, but don’t cross over into regulated territory.
- 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.
- If your app requires premarket clearance, what predicates are available and more importantly what strategies are there for showing substantial equivalence.
- Practical steps for developing an FDA quality system that is nuanced to fit mobile apps, and is designed to be as economical as possible.
- 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?
- From the perspective of seasoned executives, what are the management challenges you can anticipate in mobile app development in a regulated environment?
You will hear directly from the experts, including regulatory attorneys, regulatory affairs specialists, quality system experts, European law attorneys, experienced mHealth executives and of course, the FDA.
Who Should Attend
These workshops will focus on mobile medical apps issues that will help both the novice and experienced FDA regulatory professional alike.
Contact
For questions about the MMA Roadshow, please contact:
Lisa Blackburn
lblackburn@ebglaw.com
Sponsors
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University Sponsors
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Proposed Legislation to Remove FDA Oversight of Medical Software Would Put Patients at Serious Risk
Alliance of Healthcare Providers, Device and Software Makers Says Congress Shouldn’t Short-Circuit FDA Progress in Parsing High Risk, Low Risk Apps
WASHINGTON — Legislation that would remove a wide range of mobile healthcare applications and other medical software from federal oversight would pose serious, potentially life-threatening risks to patients and consumers. Rather than pre-empting the ongoing Food and Drug Administration (FDA) effort to identify low risk apps that shouldn’t require FDA review, Congressional staff should participate in the FDA process, holding the agency accountable for moving quickly and achieving the right balance.
For the full release, click here Proposed Legislation to Remove FDA Oversight of Medical Software Would Put Patients at Serious Risk.
San Diego health app developers hear from FDA
Union-Tribune San Diego, January 27, 2014
About 100 people attended the event at UC San Diego, where FDA panelists told health care software and hardware makers that patient safety is the top priority in the FDA approval process.
http://www.utsandiego.com/news/2014/jan/27/FDA-health-app-developers-san-diego/
FDA, Industry Groups Launch mHealth Educational Outreach Tour
FDA Week, January 24, 2014
Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition and chairman of the steering committee for the program, noted that the MMA Roadshow is an efficient way for FDA to speak to a large number of mobile app developers about its guidance. There is probably a greater need for FDA education in mHealth than elsewhere, he added.
“Basically there are 12 national organizations promoting these meetings to their members, so rather than go to individual meetings with each individual association, (Patel is) able to cover all 12 of them at once,” he said. “They will be very large meetings, probably all of them over 100, and all specific to the FDA guidance.” …
Thompson said industry roadshow speakers intend to give innovators support by sharing their experiences with FDA regulation. The goal of the program is to encourage the development of apps that are higher in risk but that also offer higher benefits, he said.
“Mobile apps offer incredible opportunities to improve the quality of care, as well as its effectiveness, and so far developers have barely scratched the surface,” he said. “We hope to help more companies enter this space.”
https://healthpolicynewsstand.com/FDA-Week/FDA-Week-01/24/2014/menu-id-315.html
Brad Thompson was quoted in an article titled “FDA’s Mobile Medical Apps Guidance: Our Advisors Weigh In.”
FierceMobileHealthcare, 10/1/2013
Brad Thompson was quoted in an article titled “FDA’s Mobile Medical Apps Guidance: Our Advisors Weigh In.”
Brad Thompson Featured in Article, “FDA Emphasizes ‘Deregulatory’ Efforts in Mobile Medical Apps Final Guidance”
The Gray Sheet, 9/23/2013
Brad Thompson was quoted in an article titled “FDA Emphasizes ‘Deregulatory’ Efforts in Mobile Medical Apps Final Guidance.”
FDLI’s Annual Advertising & Promotion Conference: How Technology Is Driving Communication – Social Media Vehicles
Bradley Merrill Thompson will moderate a panel discussion, “How Technology Is Driving Communication: Social Media Vehicles,” at the Food and Drug Law Institute’s Advertising & Promotion Conference, which runs from September 16 to 17.
Although companies await guidance from FDA, they continue to use numerous social media vehicles to advertise and promote. This session will focus on the variety of vehicles that are available to companies (including well-known platforms like Facebook and newer models like Pinterest). Panelists will suggest ways to comply with existing FDA enforcement policies, and will provide advice on what practices seem beyond compliance.
For more information, visit FDLI.org.
Part 2: Set FDA’s Mobile Medical App Guidance Free [MobihealthNews.com]
Bradley Merrill Thompson wrote an article titled “Part 2: Set FDA’s Mobile Medical App Guidance Free” on MobihealthNews.com.
Following is an excerpt:
In response to my prior post on this topic, athenahealth’s VP of Government Affairs, Mr. Dan Haley took the time to write some very thoughtful-provoking comments. I appreciate him taking the time to do so. I think it probably helps everyone to have a thorough debate of these issues. So in the spirit of debate, I’d like to offer a few reactions.
As I said in my original post, it’s important for us all to keep in mind that FDA is already regulating mHealth and the purpose of this guidance is to reduce the scope of that regulation. So the question is – is it useful for FDA at this time to come out with a final guidance on mobile health?
I will explain further why I think it clearly is.
Mr. Haley offers the view that FDA guidance is unnecessary at this point because there will be a new statutory scheme within about a year. After consulting his blog that he referenced in his prior comments, it appears that Mr. Haley is a government affairs professional and an attorney, so I know that he well-understands the process for creating new statutes, but let me recite it for everyone’s benefit.