Regulatory
Our Focus
Working with our members, government officials, and other stakeholders to ensure patients have timely access to safe and effective products
MDUFA V
MDMA is working to ensure FDA meets the commitments under the MDUFA V agreement
FDORA Implementation
Working with FDA and our members to effectively implement new enhancements around cybersecurity, clinical trial diversity, PCCPs, and more
Challenges
Ongoing efforts to improve biocompatibility, human factors, and more
Efficient Regulatory Pathways Matter
Years ago, U.S. patients all too often were not the first to get access to medical technology innovations developed in the United States. MDMA gathered data to quantify the problem and advocated for least-burdensome, risk-based solutions. Regulatory programs improved, and MDMA continues to advocate for additional enhancements and improvements to the premarket review programs to ensure that U.S. patients receive timely access to safe and effective medical technologies.
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“MDMA was extremely responsive and collaborative working with our team to navigate a challenging issue facing our company and the broader industry. These efforts resulted in a great outcome for innovation and patient access.”
Jim Schuermann | President & Chief Executive Officer, Saluda Medical
“I’ve been involved with MDMA for nearly 10 years and they are the most responsive, committed and straightforward device and diagnostics professionals. We are a part of several of their working groups and feel strongly they are advocating for our business and industry.”
Peter Shearstone | Vice President, Global Quality & Regulatory Affairs, Thermo Fisher Scientific