FDA To Revamp Long-Criticized System For Approving Medical Devices
“We believe that it’s time to fundamentally modernize an approach first adopted in 1976,” FDA Commissioner Scott Gottlieb said in a statement, noting that the changes under consideration would push companies to compare their devices to more up-to-date technology. And The Associated Press reports on the challenges of tracking devices.
The Associated Press:
FDA Says It Will Overhaul Criticized Medical Device System
U.S. health officials said Monday they plan to overhaul the nation's decades-old system for approving most medical devices, which has long been criticized by experts for failing to catch problems with risky implants and related products. The Food and Drug Administration announced plans aimed at making sure new medical devices reflect up-to-date safety and effectiveness features. The system targeted by the actions generally allows manufacturers to launch new products based on similarities to decades-old products, not new clinical testing in patients. (Perrone, 11/26)
The Wall Street Journal:
FDA Is Revamping Clearance Procedures For Medical Devices
“It’s time to fundamentally modernize an approach first adopted in 1976, when Congress considered the vast diversity of devices” entering the U.S. market, senior FDA officials said in a statement disclosed Monday. The officials are FDA Commissioner Scott Gottlieb and Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health. Drs. Gottlieb and Shuren said the agency plans to drive companies “toward reliance on more modern predicate devices or objective performance criteria.” Their plan is to shift companies, if they continue with the use of predicate devices, toward those no older than 10 years rather than the 40-year precedents now. (Burton, 11/26)
The Associated Press:
Improving Medical Device Tracking A Slow, Imperfect Process
For nearly two decades, health advocates have pushed to standardize the way medical devices are tracked and studied. They eventually landed on a solution that others, including other parts of the medical industry, already had adopted — a unique code to help track the type, manufacturer and other key information about a device. In 2007, Congress asked the U.S. Food and Drug Administration to create the system, and the FDA passed a final rule establishing it in 2013. (Hoyer, 11/26)
The Associated Press:
Breast Implants Reveal Problems In Tracking Device Safety
To all the world, it looked like breast implants were safe. From 2008 to 2015, the U.S. Food and Drug Administration publicly reported 200 or so complaints annually — a tiny fraction of the hundreds of thousands of implant surgeries performed each year. Then last fall, something strange happened: Thousands of problems with breast implants flooded the FDA's system. More than 4,000 injury reports filed in the last half of 2017. Another 8,000 in the first six months of 2018. (Hoyer, 11/26)
