Category: Life Sciences

Peter Levy Authors Article in ROI-NJ Titled “Future Shock: What Happens when Medical Device Technology Moves Faster than Regulation Governing it?”

February 9, 2022

The FDA has some catching up to do on establishing clear regulations around a new class of medical devices known as “Software-as-a-Medical Device (SaMD).” Currently, technological and scientific advances are outpacing the regulators and without specific rule-sets for these innovations, many safety and security requirements and liability questions remain unknown. Peter A. Levy explores these healthcare […]