The regulation of Medical Devices is a tricky area. I have blogged before about the registration process and its critics. Now the FDA is stepping in to fund a project that aims to bring greater clarity to the medtech risk-benefit equation.
The US FDA has awarded the non-profit Medical Device Innovation Consortium (MDIC) almost half a million dollars to investigate patient preferences and ways of integrating them into the medical device development process.
Developers, regulators, and patient groups see the value in weighing device benefits and risks from the perspective of patients, but there aren’t any current guidelines on how to collect and use this data. MDIC’s one-year Patient-Centered Benefit-Risk Project, aims to produce:
- a catalogue of methods for assessing patient preferences about medical devices
- a framework for incorporating that information into device development and benefit-risk assessments, and
- an agenda for further research.
In a guidance document published two years ago, the FDA’s Center for Medical Devices and Radiological Health emphasized that “patient tolerance of risk and perspective on benefits” is an important consideration during pre-market review. The FDA guidance discusses the importance of the patient perspective in certain regulatory decisions, but stops short of outlining how such information should be collected or used.
There are many unanswered questions, such as: what types of patient preferences should be measured, and how and when should this information be provided to inform the FDA?
Hopefully the project will bring some much needed clarity.
Whitehall Training’s Device Safety and Vigilance course deals specifically with the systems and requirements for the reporting of adverse events relating to medical devices. It covers not only in the current legislative situation but also the principles of adverse event reporting and risk assessment as applied to medical devices. With coverage of risk assessment, AE report types, causality and event types, this course is designed to give a solid grounding in all key aspects of vigilance within this +$300 billion sector.
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