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Sponsors of device clinical trials should carefully examine the demographic distribution of study participants at various points during the study, the FDA says in final guidance published Wednesday. Read More
A former FDA employee plans to press forward with efforts to remove Lasik eye surgery devices from the market following the agency’s denial of his citizen petition seeking the ban. Read More
The FDA has released a three-point action plan aimed at encouraging more diverse patient participation in medical device and drug clinical trials. Read More
The Centers for Medicare & Medicaid Services will launch its Sunshine Act open payments database on schedule next month, but about a third of submitted data won’t be posted, the agency said Aug. 19. Read More
The Internal Revenue Service may soon begin sending reminder notices to devicemakers it suspects of failing to pay the new 2.3 percent medical device excise tax after the agency found revenues from the tax fell more than $250 million short of expectations in the first half of 2013. Read More
Citing industry concerns, the FDA has reversed plans for a proposed voluntary presubmission process that would have allowed sponsors to get reviewer feedback before submitting an investigational device exemption application. Read More
Devicemakers could spare themselves time and money by checking with UDI-issuing agencies to see if they have a current account before applying for new licenses, a former FDA official says. Read More
The International Medical Device Regulators Forum has released two final guidance documents aimed at easing the filing process for marketing authorizations of medical devices and in vitro diagnostic devices in multiple countries. Read More
The FDA is looking for participants for a pilot program that will help the agency design and validate regulatory tools for use in developing new technologies. Read More
The FDA has published a unique device identification compliance guide aimed at helping small manufacturers prepare for UDI implementation, the first stage of which comes due next month. Read More
Manufacturers may soon be able to check how their devices are progressing through the 510(k) review process, under an experimental program being developed by the FDA. Read More
New requirements for the clinical evaluation of medical devices in China, part of a regulatory overhaul that took effect June 1, could slow the introduction of innovative technologies there, an industry observer says. Read More