The FDA and the inadequate vetting of new medical devices

The law governing the regulation of medical devices allows companies to claim their new product is “substantially equivalent” to something already approved by the FDA and needn’t undergo clinical trials in humans. All too often, this new device contains a significant change that winds up killing patients.

In this podcast, a physician whose own family was devastated by one such device explains why and how the regulatory framework for approving these supposedly follow-on devices — known as the 510(k) pathway after the legal section that allows it — has to change.