The International Medical Device Regulators Forum has issued a proposed update to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices, with advice on the design, implementation, and appropriate use of these studies.
The update outlines when a PMCF study is indicated, the general principles of PMCF studies for medical devices, the design and implementation of studies, and the use of the clinical information. The document does not apply to in vitro diagnostic devices.
The proposal, which is open for consultation until 11 December 2020, was issued by the group’s Medical Devices Clinical Evaluation Working Group.
“Complete characterization of all risks and potential benefits may not always be possible or practicable in the premarket phase. Therefore, there may be uncertainties (such as rare adverse events, potential benefits, long-term safety, clinical performance and/or effectiveness,) that should be addressed in the postmarket phase using one or more systematic postmarket clinical follow-up (PMCF) studies,” the working group wrote. “PMCF studies are not intended to replace the premarket data necessary for market authorization. PMCF studies are one of several options available in a postmarket surveillance program and contribute to the risk management process.”…