FDA Guidance Looks At Benefit Vs. Risk In Certain 510(k)s
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FDA issues a draft guidance July 15 describing how it weighs the risks and benefits to prove substantial equivalency in 510(k) devices when the new product’s technological characteristics differ from its predicate device.
Medtronic’s MiniMed 600 series of insulin pumps is the subject of a high-risk class I recall because a component may break, leading to over- or under-dosing of insulin. The company warned patients of the issue last November.