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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
The FDA has rejected a call for a total ban on transvaginal mesh products, saying complete market withdrawal is not an appropriate way to deal with serious safety concerns linked to the devices. Read More
Canadian devicemakers are praising their government’s plan to implement an internationally harmonized system of unique device identification, but say it must become “truly global” to avoid additional barriers to trade. Read More
The FDA roundly rejected a citizen’s petition from the Minnesota Medical Device Alliance that had sought multiple changes to the 510(k) notification process. Read More
Manufacturers of moderate-risk devices with a good record of GMP compliance could see less of government inspectors, under proposed amendments to South Korea’s good manufacturing practice regulations. Read More