We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Malaysia’s Medical Device Authority has released a 12-step guideline for submitting registration applications for in vitro diagnostic products through the agency’s web-based system. Read More
A Federal Trade Commission report on data brokers suggests that devicemakers should take extra steps to protect personally sensitive information, one attorney says. That includes incorporating data protection clauses into third-party contracts. Read More
The FDA is classifying pancreatic drainage stent and delivery systems as Class II with special controls, but will still require premarket notification before distribution. Read More
Stryker has publicly denied any immediate plans to acquire British devicemaker Smith & Nephew, but left open the door for a future takeover bid. Read More
The Obama administration has radically reinterpreted the doctrine of preemption in pressing the Supreme Court not to hear a case involving a Medtronic pain pump, attorneys familiar with the U.S. solicitor general filing say. Read More
The Centers for Medicare & Medicaid Services has set June 1 as the start date for Phase 2 of Open Payments data submissions under the Physician Payment Sunshine Act. Read More
Sen. Patrick Leahey (D-Vt.) effectively killed any chance at patent reform legislation by removing H.R. 1720 from the agenda of the Senate Finance Committee, which he chairs. Read More
Argentina’s ANMAT has adopted strict traceability requirements for medical devices, with the aim of stemming the flow of counterfeit products. Read More