FDA Finalizes Post-Market Benefit-Risk Guidance
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.
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'A Sea Change': Device Center Compliance Chief Touts US FDA's Benefit-Risk Concepts – But Will Manufacturers Buy In?
FDA compliance head Robin Newman is asking manufacturers to share information on troublesome devices to help the agency make benefit-risk decisions that weigh product availability and regulatory compliance. But an industry survey finds that only 17% of firms are willing to hand over such potentially sensitive information. Nevertheless, the agency believes it's vitally important for device-makers to be more forthcoming with data that supports well-informed benefit-risk conclusions, made in the best interest of patients and manufacturers. Driving the data-sharing discussion is a December guidance from FDA that outlines a broad framework for considering benefit-risk factors – a document that Newman says is "a sea change" for how industry and the agency can work hand-in-hand on benefit-risk analyses.
Warning Letter Nosedive: US FDA Writes Fewest Quality-Related Missives Since 2002; Agency Isn't Sure Why
Only 57 quality-related warning letters were issued to device manufacturers in 2016, a 14-year-low that has left US FDA scratching its head as to why so few were sent to firms. "Our analyst team talked to both managers and staff alike within the device center, within ORA, and we could not identify a single factor or event to attribute the drop to," FDA compliance office official Sean Boyd said in an interview. Also: US inspections are down 2%, while foreign audits are up 16%; the top three quality system violations are revealed by FDA; an update on the number of close-out letters sent to firms; and more.
This is Compliance 360°, a podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this eighth installment, former FDA investigations branch director Ricki Chase explains how the role of the patient influences FDA's enforcement strategy and discusses the agency's recent industry guidance on benefit-risk factors.