Australia Recalls Rehab Assist’s Carry Bars for C-Series Ceiling Hoists September 30, 2016 Nine incidents of damage to the bar’s plastic swivel have been reported. Read More
Upcoming Rules in Australia to Allow Earlier Access to Medical Devices September 30, 2016 Greater reliance on approval by foreign authorities is proposed. Read More
Guidance Addresses Computational Modeling in Device Submissions September 30, 2016 FDA seeks to pave the way for increased use of computer modeling in device trials. Read More
CDRH Outlines Regulatory Priorities for Fiscal 2017 September 30, 2016 Priorities center on expanded collection of data and new ways to manage it. Read More
Senators Urge DOJ Probe of EpiPen Generic Classification September 29, 2016 Mylan paid a 13 percent Medicaid rebate rather than the standard 23.1 percent. Read More
EU Deliberates Joint Health Technology Assessments September 28, 2016 The pathway to market access is dictated by individual member states. Read More
HHS Releases Final Rule for Clinical Trial Information Reporting September 27, 2016 The final rule increases the requirements for submitting registration and results information. Read More
FDA Labels Magnetic Surgical Instrument Systems as Class II September 27, 2016 Firms that intend to market this type of device must submit a premarket notification. Read More
Dual Antimicrobial-Testing Development Outlined in Guidance September 27, 2016 The FDA guidance describes interactions between devicemakers and drug sponsors for coordinated development. Read More
Chinese FDA Builds on Medical Device Submission Document Requirements September 26, 2016 Device manufacturers with Class II and III devices will have to include additional copies of registration. Read More
House Committee Rebukes Mylan CEO, FDA Official on EpiPen Fee September 26, 2016 Mylan CEO grilled on virtual monopoly of the epinephrine auto-injector market. Read More
FDA Deficient in Capacity to Regulate Laboratory-Developed Tests, Senators Say September 26, 2016 Most tests are regulated by the Centers for Medicare & Medicaid Services. Read More