Regulatory and Compliance
May 05, 2016
Marie Thibault Putting to rest some speculation about what the initiative’s future will be, a CMS leader confirmed today that the Parallel Review program will...
Apr 29, 2016
Marie Thibault Dexcom has long envisioned a future where patients with diabetes don't need confirmatory fingersticks to make decisions about their treatment....
Apr 27, 2016
Why doesn't FDA mention its own human factors guidance in another recent technology-specific guidance document? William A. Hyman On April 20, 2016, FDA issued...
Apr 25, 2016
Marie Thibault Congress has focused in recent years on easing the regulatory burden for medical device makers. But since reimbursement hurdles often outweigh...
Apr 22, 2016
Marie Thibault FDA has proposed prohibiting electrical stimulation devices (ESD) used to treat aggressive or self-injurious behavior, a move that would...
Apr 20, 2016
Marie Thibault Fisher Wallace Laboratories, makers of the Fisher Wallace Stimulator, urged supporters to submit comments on the FDA proposal. Dozens of...
Apr 18, 2016
Patients injured by medical devices have stepped up their attack on CDRH director Jeffrey Shuren, appealing to Congress to fire him. Jim Dickinson The...
Apr 15, 2016
Why is FDA proposing a ban for powdered gloves but shows no signs of pursuing a ban for other devices that have raised patient safety concerns? Nancy Stade, JD...
Apr 13, 2016
Marie Thibault A public-private partnership has put forth a draft blueprint intended to give medical device companies a helping hand in planning and...
Apr 12, 2016
Marie Thibault The Dexcom G4 Platinum receiver is one of the model types subject to the recall. Users have been urged to test the audio alert function. Dexcom...