The future regulation of mobile healthcare in the US
This article was originally published in RAJ Devices
Bradley Merrill Thompson looks at the evolving regulatory status of mHealth products and describes the complex and unique challenges that lie ahead.
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Currently, FDA has several statutorily-based authorities to require companies to undertake post-market corrective action, and each one of them is designed to give the manufacturer an opportunity to present its perspective and any evidence supporting the approach the company proposes to take.
Strengthening the flow of real-world evidence on medical devices is at the heart of US FDA's evolving paradigm of device oversight. An underlying promise of the new approach is that a better post-market safety net will allow the agency's device center to take more risk in the pre-market phase, accelerating product development. But while safety surveillance is an important goal, the device center's recent actions and its April-issued Medical Device Safety Action Plan signal that it wants dramatic changes in its authority to decide how best to respond to perceived post-market safety signals, carrying potentially significant negative consequences for the public health, argues attorney Bradley Merrill Thompson in this guest column.