Reader Consult: What Could Take the Place of the 510(k) Process?

Medical-device regulation is a tricky balancing act. Consumer advocates say the current process doesn’t ensure the safety and efficacy of devices on the market, while the device industry says the FDA’s process is inefficient and expensive and keeps products from reaching patients in need.

Today, as the WSJ reports, the Institute of Medicine weighed in with its own much-anticipated report on device regulation. Notably, an 11-member committee recommends scrapping entirely the streamlined approval pathway known as 510(k), under which a device such as a joint replacement or heart defibrillator can be approved …