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.
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.
Cytori Therapeutics Inc. , a developer of medical devices, may need to spend $10 million more and take five years longer to win U.S. approval of its first product, under regulation stricter than the company expected.
Bristol-Myers Squibb Co. and Eli Lilly & Co. won U.S. regulatory approval to expand the use of Erbitux as an initial treatment against colorectal cancer that has spread for patients who are first given a genetic screening.
High-risk medical devices are approved for sale without sufficient proof of safety by U.S. regulators who don’t monitor recalls when concerns arise during marketing, the Government Accountability Office found.