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.
Software to help diabetics manage their condition has advanced significantly in recent years, but gaps in regulation and interoperability issues are hindering access, industry and patient groups told the FDA Thursday. Read More
The European Commission is again seeking input on the risks associated with di(2-ethylhexyl) phthalate plasticized PVC in medical devices, saying more data is needed before banning its use. Read More
Devicemakers may use alternative approaches to dual boot designs in new submissions for molecular diagnostic tools that combine approved and unregulated functions if they demonstrate that the nonregulated functions don’t interfere with the approved ones, FDA final guidance says. Read More
A sweeping rewrite of Canada’s drug safety law that authorizes the government to order recalls and require labeling changes and postmarket studies could spell new worries for devicemakers because it also allows for the release of confidential business information on unsafe products. Read More
The FDA plans to tighten restrictions on dozens of spinal screws already on the market, requiring new PMAs for dynamic stabilization systems that are used to treat severe spondylolisthesis, fracture, dislocation, scoliosis and spinal tumors. Read More
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