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The FDA released draft guidance outlining the performance criteria sponsors of certain magnetic resonance coils should use to support substantial equivalence instead of a direct comparison. The guidance applies to sponsors who wish to submit a 510(k) application using the agency’s Safety and Performance Based Pathway. Read More
GSK demanded that BI stop using a brochure which claimed that a majority of COPD patients would be unable to fully benefit from Ellipta and Diskus. Read More
Most comments supported aligning the classification levels with either the EU Medical Device Regulation or the classification principles of the International Medical Device Regulators Forum. Read More
“BioCorRX and the [Louisiana Department of Public Safety and Corrections] conducted what clearly amounts to a clinical investigation testing a sustained-release naltrexone implant in prison inmates,” according to the Public Citizen petition. Read More
Premarket application holders of Class III devices subject to approval that are impacted by the changes may request the agency’s permission to file a post-approval report rather than submit a PMA supplement. Read More
Health Canada is creating a stand-alone Medical Devices Directorate (MDD) within its Health Products and Food Branch that will take a “lifecycle approach” and also take on postmarket functions currently within the Marketed Health Products Directorate Read More