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Guidance on Making Benefit-Risk Determinations
Jim Dickinson
May 2, 2012
1 Min Read
.svg?width=850&auto=webp&quality=95&format=jpg&disable=upscale "Guidance on Making Benefit-Risk Determinations")
CDRH has issued a first-of-a-kind guidance: "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications [PDF link]." The guidance describes how the benefits and risks of certain medical devices are considered during pre-market review. An agency news release says the guidance includes a worksheet for device reviewers incorporating the principal factors that influence risk/benefit determinations, such as the type, magnitude, and duration of a risk or benefit, the probability that a patient will experience the risk, patient tolerance for risk, availability of alternative treatments, and the value the patient places on treatment.
The release says the guidance:
outlines the systematic approach FDA device reviewers take when making risk/benefit determinations during the PMA pre-market review process.
provides manufacturers a helpful tool explaining the various principal risk factors considered by the agency during the review of PMA applications and de novo petitions.
describes an approach that takes into account patients’ tolerance for risks and perspectives on benefits, as well as the device’s novelty.
FDA will also increase the transparency of the decision-making process by describing the worksheet analysis in the Summary of Safety and Effectiveness Data for PMA and the decision summary review memos in de novo decisions, the release says.
Center reviewers were to begin applying the guidance to income submissions and to submissions already under review with decisions beginning May 1.
The guidance is available online.
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