US FDA Pilot Programs Identified Need For Post-Market Benefit Awareness
FDA pilot programs conducted before the issuance of a recent final guidance document on benefit-risk factors for post-market decisions found that the agency needed to work on questions used to evaluate the benefits of marketed products, an agency official said.
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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.
The guidance document attempts to help manufacturers and the agency consistently apply benefit-risk factors in making decisions about non-conforming products on the market and regulatory compliance issues. It is part of FDA’s larger effort to harmonize risk-benefit standards throughout the agency’s device center.
Sponsors participating in the US FDA’s Accreditation Scheme for Conformity Assessment pilot program should work closely with the lab and be prepared for a few extra steps in putting a submission together, agency staff say.