Stakeholders Give FDA An Earful; Poor Communication, Recall Inefficiency, Patients At Risk
During a recent listening session on modernizing its recall process, the US FDA heard from industry, consumers, and patients — all of whom expressed a common theme: the agency needs to up its game in how it handles recalls.
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Legislation introduced in both houses of Congress would improve how the FDA handles medical device recalls by requiring the agency to establish an electronic format to streamline communication among stakeholders.
During a recent summit, the Medical Device Innovation Consortium Case for Quality Collaborative Community introduced a new risk-based CAPA framework that moves away from the current compliance-focused “one-size-fits-all” approach to a more comprehensive strategy. The summit also discussed how the industry can more effectively and quickly notify consumers about recalls.
The US agency announced this week that it’s reviewing multiple reports of a form of carcinoma that arises in the scar tissue around a breast implant.