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# Guide on Uncertainty in Device Benefit-Risk Determinations
- URL: https://www.fdaweb.com/guide-on-uncertainty-in-device-benefit-risk-determinations/
- Published: 2018-09-06T12:00:00.000Z
- Updated: 2026-09-15T00:30:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142286

*Federal Register* notice: FDA has made available a draft guidance entitled “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” As a general matter, high-risk and innovative moderate-risk devices will “typically need clinical evidence to show reasonable assurance of safety and effectiveness, including that the benefits of the device outweigh its risks,” the notice says. “However, non-clinical performance data, such as bench studies, studies in animals, and/or computational modeling studies can also provide essential information on the safety and effectiveness of a device (including its principles of operation, as well as potential failure or malfunction modes).” To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-09-06/pdf/2018-19249.pdf?ref=fdaweb.com).