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A Federal Communications Commission proposal to amend hearing aid compatibility rules is coming under fire from one commissioner, who is concerned that some of the ideas expressed in the plan would allow for “inappropriate” FCC intervention in the standards development process. Read More
A lawmaker is taking the FDA to task after a Government Accountability Office report determined that more than 70 percent of postapproval studies ordered by the agency since January 2007 are ongoing. Read More
The European Commission should take additional steps to ensure that experts sitting on scientific committees that make decisions on medical products are truly independent. Read More
The UK’s health cost-benefit watchdog is calling for further research on two tests that could help diagnose preeclampsia in the second and third trimesters of pregnancy. Read More
Mexico’s health agency is seeking to obtain certification in medical devices from the World Health Organization and Pan American Health Organization next year. Read More
Speaking at the AdvaMed 2015 conference in San Diego, Calif., in October, an FDA representative and champion of the International Medical Device Regulators Forum Medical Device Single Audit Program renewed her call for participants in a pilot for the initiative, as companies have proven reluctant to join. Read More
For devicemakers concerned about complying with the 2013 final rule on combination products, one quality systems expert has this advice: Don’t panic. Read More
What are the barriers holding stakeholders back from having a shared view of risk? That question was at the heart of discussions held during a summit co-convened last week by the Association for the Advancement of Medical Instrumentation and the FDA. Read More
Russia’s device authority is taking a strong stance against counterfeit and unregistered products, according to representatives at separate events this month. Read More
Olympus America, Fujifilm Medical Systems and Pentax’s Hoya unit have 30 days to submit postmarket surveillance studies to the FDA detailing how their duodenoscopes are reprocessed in healthcare facilities. Read More
The International Medical Device Regulators Forum has unveiled a document it hopes will help industry understand how quality management can play a role in ensuring the quality and safety of devices that rely on software. Read More