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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
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
All devicemakers holding CE certificates for Class IIa medical devices and higher should be prepared for unannounced quality system visits by notified body inspectors. Read More
BALTIMORE — Devicemakers in the process of setting unique device identification codes with the FDA may want to bake in some extra time, agency officials say. Read More
Medicare spent a total of $1.9 billion in 2009 on 26 different tests and procedures that offered little or no health benefit, according to a new report by researchers at Harvard University, who found that a quarter of Medicare recipients received at least one of the services. Read More
A recent court decision to broaden the scope of the Foreign Corrupt Practices Act could mean increased risks to devicemakers, one attorney says. Read More
The Centers for Medicare & Medicaid Services is broadening the scope of its prior authorization program for power mobility devices, expanding it geographically. The program determines whether items meet Medicare coverage requirements before they reach beneficiaries. Read More