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)
MRC White Paper: Consumer Medical Devices Used To Manage Health
MRC Consumer Medical Devices Used to Manage Health White Paper (July 3, 2014)
MRC Comments to the IMDRF Proposal
Comments to “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls”
“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.
MCT-Congress ~ Edinburgh, Scotland ~ March 20-21, 2014
Bethany Hills will be presenting Beyond FDA: Overcoming Regulatory Hurdles on behalf of the mHealth Regulatory Coalition at the Inaugural MCT-Congress in Edinburgh, Scotland on March 21, 2014.
The MCT-Congress – a new cutting edge conference put together by the industry leaders – will explore the impact that mobile solutions are having on the clinical research process.
For more information: http://www.mct-congress.co.uk
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/
Attorneys, FDA and industry groups have teamed up to tour the country and educate innovators on how to navigate mobile medical app regulations.
The Gray Sheet, January 27, 2014
“The idea is to give innovators support by sharing experience,” Bradley Thompson, a lawyer at Epstein Becker & Green and the head of the mHealth Regulatory Coalition, wrote “The Gray Sheet” in an e-mail.
To that end, Thompson organized the tour, focusing on universities as “hubs of innovation.” Each stop will feature several speakers and groups: Bakul Patel, senior policy advisor at CDRH who spearheads the center’s mobile health policy development; a lawyer from Epstein Becker & Green; Erik Vollebregt, a lawyer from Axon Lawyers in Amsterdam, discussing the impact of European Union regulations in mobile health; and local developers who have already taken apps through FDA’s clearance and pre-market process.
For the full article: http://www.elsevierbi.com/publications/the-gray-sheet/40/4/attorneys-fda-hit-the-road-to-instruct-on-mobile-health-regs
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