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.
Devicemakers faced myriad challenges in 2013, as new rules and practices went into effect under the Affordable Care Act, FDASIA and the Physician Payment Sunshine Act. FDA offered guidance on a number of issues, including IVDs for research use only, medical device development tools and priority reviews. Globally, the year saw a steady push toward enactment of new device regulations in the EU, clampdowns on industry bribes in China and Brazil, and strict clinical trial compensation rules in India, to name just a few key developments. Here are 10 issues that kept industry buzzing this year. Use this list to review your regulatory program and prepare a successful business strategy for 2014.Read More
The FDA’s final guidance on unique device identification should allow for submission of UDI data elements within 10 days of commercializing a device, rather than requiring that they be in the Global UDI Database before market launch, as the stricter requirement could lead to lost sales, AdvaMed says. Read More
Health product safety legislation introduced by Canada’s conservative government would require devicemakers to revise product labels to reflect new risk information, including updates on pediatric warnings, and conduct further tests when issues arise around at-risk populations. Read More
A proposed policy that would allow hospitals to set their own maintenance schedules for medical equipment could pose a significant risk to users of imaging and radiological devices, a coalition of medical societies says. Read More
A bill to regulate medical apps according to risk continues to spark debate, with supporters saying it is needed to protect innovation and detractors saying it is premature. Read More
Industry can expect an international effort to revise and update software device standards over the next few years, CDRH Director Jeffrey Shuren says. Read More
The FDA’s final guidance on unique device identification should allow for submission of UDI data elements within 10 days of commercializing a device, rather than requiring that they be in the Global UDI Database before market launch, as the stricter requirement could lead to lost sales, AdvaMed says. Read More
An FDA review of Mectra Labs’ website found that the company was offering a new size of its MAGI and ALIEN insufflation needles without clearance or approval, prompting a warning letter. Read More