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An FDA warning letter last year to Biosense Technologies was a heads-up to mobile app developers, but “the fears of the mobile app industry … that the letter to Biosense represented some new trend of aggressive FDA enforcement” have not come true, one expert says. Read More
As the clock ticks down for high-risk devices to comply with the FDA’s unique device identifier rule, the first organization accredited to issue UDIs is offering devicemakers some advice. Read More
A group of FDA task forces Tuesday recommended that the agency expand the amount of information it releases on inspections and enforcement, allowing the public to view a more detailed record of a company’s compliance history. Read More
The FDA may approve devices whose benefit-to-risk ratio is less certain if that uncertainty is “sufficiently balanced” by other factors such as postmarket controls, the agency says in draft guidance published Wednesday. Read More
Cuts in national payment rates for medical imaging may be behind recent drops in utilization, but a 2012 requirement that providers be accredited probably is not, the Government Accountability Office says. Read More
Overall reports of adverse events declined over the past three years from 21,729 in 2011 to 14,819 in 2013, according to data published by the UK’s Medicines and Healthcare products Regulatory Agency. Read More
The FDA plans to release a document later this year that will explain how devicemakers can use the agency’s benefit-risk framework for device approval when designing different types of clinical trials, CDRH Director Jeffrey Shuren said Wednesday. Read More
The FDA Tuesday proposed a new, voluntary program to speed the approval of devices that address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions. Read More
Snoqualmie, Wash., devicemaker Spacelabs Healthcare sent an Urgent Medical Device Correction letter to customers March 11, warning of a defect in the version 2.0 software accompanying its Arkon anesthesia delivery system. Read More
DexCom, a San Diego maker of continuous glucose monitors, has been warned over medical device reporting failures and problems with its MDR procedure. Read More