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The FDA is looking to stakeholders for input on how to overcome barriers to access and spur the development of hearing aids — devices that often are underutilized by hearing-impaired people. Read More
The FDA’s Office of Regulatory Affairs is making progress on its new program alignment and released information on what the new structure will look like. Read More
Sunlamp manufacturers would be required to take additional measures to improve the overall safety of tanning beds under new rules proposed by the FDA. Read More
With the FDA expected to issue final guidelines on laboratory-developed tests in the coming months, devicemakers should take steps now to ensure their quality systems are in place, an industry expert says. Read More
Manufacturers of electrically powered medical devices should provide information, such as summary testing and specifications, to demonstrate their products don’t pose a risk of electromagnetic interference. Read More
The FDA is terminating its ISO 13485:2003 Voluntary Audit Report Pilot program effective March 31, in an effort to help manufacturers transition over to the Medical Device Single Audit Program. Read More
The FDA is seeking input from stakeholders on potential solutions to address the scientific and regulatory challenges for a certain type of point of care in vitro diagnostic that monitors warfarin. Read More
China’s FDA has unveiled plans to assemble an expert committee to review and discuss medical device classification, as well as spelling out the rules for using generic names for devices. Read More
Devicemakers should submit a letter of intent to the European Medicines Agency at least six months in advance before they plan to seek an initial consultation on an ancillary medical substance or ancillary human blood derivative incorporated in a device, according to a new question & answer guidance. Read More