Devices May Be Over-the-Hill, but Regulatory Developments and Challenges Show No Signs of Slowing Down

This year marks the 40th anniversary of the Medical Device Amendments. Some might think that the MDA’s ruby anniversary would be celebrated by stability, predictability, and a general easing of regulatory developments and challenges. Thanks to technological developments in digital health, laboratory testing (e.g., genetic tests), and combination products, however, there is no shortage of new ways to analyze and interpret the 40-year-old MDA and its implementing regulations. The FDLI Annual Conference highlighted all of these areas and more.

Discussed below are some of the issues that appear to be most in flux with respect to FDA’s regulatory oversight and therefore, where industry can expect to see the most movement over the next few years.