Devices

2 Medical Device Benefit/Risk Guidances

FDA has published two guidances relating to making benefit/risk determinations in certain medical device applications. The first guidance, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions, describes the agency’s current approach to considering uncertainty in making benefit/risk determinations to support FDA premarket decisions for PMAs, De Novo requests, and HDE applications. The document says the agency believes the approach described in it “promotes the public health by helping patients have timely access to new medical devices meeting the applicable statutory standard for safety and effectiveness, such that probable benefits of device use outweigh the probable risks and the device will provide clinically significant results in a significant portion of the target population, based on the totality of the valid scientific evidence.

In the guidance are an Introduction, Background, Scope, Consideration of Uncertainty in Making Benefit-Risk Determinations to Support Certain Premarket Decisions, and Application: Breakthrough Devices and Devices for Small Populations, Subject to PMA.

The second guidance, Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications, is intended to provide greater clarity for agency reviewers and industry on the principal factors FDA considers when making benefit-risk determinations using the premarket review process for certain medical devices. “FDA believes that the uniform application of the factors listed in this guidance document will improve the predictability, consistency, and transparency of the premarket review process,” the document says.

Included in the guidance are an Introduction, Scope, Background, Factors FDA Considers in Making Benefit-Risk Determinations, Examples of Benefit-Risk Determinations, and three Appendices.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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