Multiple Studies Highlight the Safety and Efficacy of the FDA’s Regulatory Pathways for Medical Technology

The FDA’s regulatory pathways are the gold standard in providing safe and effective medical technologies for providers and patients. It is critically important that medical technology innovators have a predictable regulatory pathway to the market. The variability that existed over the years resulted in costly delays, and in some cases forced companies to shut down. An unpredictable and unreasonable regulatory environment leads to patients unable to access to safe and effective products.

Additionally, there has been no credible evidence to suggest that the current premarket review of medical devices is inadequate or unsafe.


The Medical Device Manufacturers Association (MDMA) is a national trade association based in Washington, DC providing educational and advocacy assistance to innovative and entrepreneurial medical technology companies. Since 1992, MDMA has been the voice for medical technology innovation, playing a proactive role in helping to shape policies that impact the ecosystem. This is accomplished by working with key Members of Congress, senior staff at FDA, CMS and other agencies, and through the grassroots support of our members.