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The FDA is strengthening its bioresearch monitoring program as part of a sweeping plan to overhaul its approach to inspections and regulatory monitoring. Read More
CMS’s final rule updating and revising the end-stage renal disease prospective payment system for 2015 nudges up the ESRD PPS base rate to $239.43, from the base rate of $239.02 in 2014. Read More
For the first time, devicemakers will have to report financial payments to continuing medical education programs (CME) under the Physician Payments Sunshine Act. Read More
FDA regulations have gotten more restrictive and lengthy, with new data showing regulatory restrictions increased by a double-digit percent from 2000 to 2012. Read More
The FDA is seeking a court order to force a retired dentist in South Dakota to pull the laser devices he manufacturers from the market, but the defendant maintains he has the right to sell the devices through a private membership association. Read More
The FDA is seeking input on its efforts to facilitate patient participation in the regulatory approval process and on ways to assess those patient engagement activities. Read More
With FDA already raising concerns about cybersecurity vulnerability in medical devices, CMS may be the next agency to jump in with an HHS audit planned for next year. Read More
Devicemakers need to be vigilant against possible embedded medical device software vulnerabilities as the FDA continues to develop a formal cybersecurity strategy, a security expert warns. Read More
With a comprehensive regulatory framework for devices set to take effect on Nov. 25, Japan’s Pharmaceutical and Medical Devices Agency still hasn’t published many of the implementing regulations, leaving industry to guess how best to prepare. Read More
The Center for Devices and Radiological Health is steadily chipping away at premarket approval and 510(k) review times, but not fast enough to compete with EU approval times, according to a new report. Read More
The U.S. Food and Drug Administration took another step toward regulating laboratory-developed tests, with the Oct. 3 publication of draft guidance on a proposed regulatory framework and another guidance on adverse event reporting. Read More
The U.S. Food and Drug Administration has reversed a controversial position and won’t require devicemakers to submit formal reports when they make safety enhancements to their products. Read More