Medical Device Makers Face Revamped U.S. Rules for Approvals

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 released the proposed new requirements for the so-called 510(k) program that covers products similar to previously approved devices, or about 90 percent of products cleared for sale.