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Makers of low and moderate risk devices can now use the U.S. Food and Drug Administration’s de novo pathway to gain approval without first filing for 510(k) clearance — a route the agency hopes devicemakers will take. Read More
Devicemakers could see their wait time to begin clinical trials cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than in stages, as is the current practice. Read More
The European Commission will soon launch an internal test of the International Medical Device Regulators Forum’s table of contents for medical devices and IVDs — documents designed to ease marketing authorizations process when companies file in multiple countries. Read More
When preparing 510(k) submissions, devicemakers should never forget that the “devil is in the details,” a regulatory adviser says. Companies would do well to have a second set of eyes review the submission after any work or changes to guard against mistakes. 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