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FDA Guidance Looks At Benefit Vs. Risk In Certain 510(k)s

Executive Summary

A newly finalized guidance document from US FDA explains how the agency will evaluate benefit and risk questions for substantially equivalent products with differing technological characteristics.

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Benefit-Risk Is Front-And-Center In Latest Revision Of International Risk Management Standard ISO 14971

The International Organization for Standardization (ISO) has strengthened benefit-risk language in the latest redo of ISO 14971, the voluntary standard that instructs device-makers on how to best put together a risk management program. Regulators – including US FDA – are increasingly considering benefit-risk when weighing product availability and regulatory compliance issues. And Jos Van Vroonhoven, convener of a joint working group that revised the standard, says a more global regulatory emphasis on risk management and a desire to clarify the document in general led ISO to revise the standard. Also: Van Vroonhoven identifies four updated clauses in the revamped standard that firms should keep a sharp eye on.

FDA Provides Guidance On 510(k) Devices With Different Technological Characteristics

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