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.
The Centers for Medicare and Medicaid Services (CMS) will draft a proposed rule that would create an expedited Medicare coverage pathway for medical devices, according to a CMS op-ed piece published in JAMA Internal Medicine. Read More
Quality management in the supply chain relies on traceability of and accountability for device components and finished products anywhere in the world, according to one supply chain management authority. Read More
The FDA has announced the launch of a pilot program to give faster and more widespread access to medical devices of public health importance and strengthen the agency’s Breakthrough Devices program. Read More
“For the time being, Lumos does not intend to further invest in activities directed towards securing U.S. clearance for FebriDx,” the company said. Read More
The FDA has extended the comment period for its draft guidance on LASIK devices by 30 days in response to multiple requests by device groups. Read More
Within days of the reauthorization by Congress of the FDA’s user fee programs for the next five years, the agency posted its fiscal 2023 device user fees – increasing most of them by a hefty 18 percent and a couple by more than 50 percent. Read More
The FDA offers advice on postmarket surveillance and postapproval studies for moderate and high-risk devices in two final guidance documents released yesterday. Read More
Flawless Beauty and Skin is importing and marketing unapproved devices, according to a warning letter the FDA sent the Ocean, N.J., firm following an inspection at that facility Nov. 16, 2021, through Jan. 19, 2022. Read More