FDA Warning Letter Recap, March 2022: Quality Systems Run Amok
A handful of domestic and foreign manufacturers were dinged by the US FDA for problems with quality systems. The agency released five device-related warning letters last month.
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Medtech Monthly is here! Check out the first episode of Medtech Insight's new podcast series: It's a knock-down (not really), drag-out (not really), freewheelin' (very much so) conversation about quality versus compliance, with the US FDA's Cisco Vicenty in one corner, and former FDA compliance chief Steve Silverman in the other.
The US FDA compliance officer says medtech manufacturers would be wise to evaluate changes to stay out of hot water with the agency.
The US FDA is teaming up with the Medical Device Innovation Consortium to establish the clearinghouse, which would nudge medtech companies to adopt novel approaches that could take their manufacturing operations to a higher level.