Medical device makers Medtronic Inc. , Johnson & Johnson and Stryker Corp . face new safety rules under a revamped program laid out by U.S. regulators that may help speed approval of products from condoms to CT scanners.
The Food and Drug Administration’s top medical-device regulator said the agency needs more power to block unsafe products and prevent repeats of faulty hip implants and vaginal mesh that sparked thousands of patient lawsuits.
Medical device makers have spent the last year urging U.S. officials to approve high-risk products faster, like their European counterparts. A scandal over leaking breast implants made in France may make the argument harder.
A wearable artificial kidney and two other devices to treat renal failure will get fast-track reviews under a program U.S. regulators say can cut the time it takes to get “breakthrough” medical technology to market.
Johnson & Johnson, the world’s second-biggest health-care products maker, is battling lawsuits over a vaginal implant based on a similar device pulled from the market more than a decade ago for safety reasons.
U.S. regulators will strengthen their oversight of medical devices used at home as part of an initiative to improve safety of the increasingly popular products, according to information posted today on the Food and Drug Administration’s Web site.
U.S. regulators would gain greater authority to track the use of devices, such as hip implants from Johnson & Johnson and vaginal meshes made by Boston Scientific Corp., that have sparked thousands of patient lawsuits, under a bill introduced in the Senate.
Gene-sequencing breakthroughs, spawning a fast-growing, multibillion-dollar market for drugs and medical tests, are also creating thorny questions over how to regulate commercial use of the human genetic code.