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# Draft Device Uncertainty Determination Guidance
- URL: https://www.fdaweb.com/draft-device-uncertainty-determination-guidance/
- Published: 2018-09-05T12:00:00.000Z
- Updated: 2026-09-15T00:30:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142265

FDA has issued a draft guidance, *Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions*, describing the agency’s current approach to considering uncertainty in making benefit/risk determinations for some medical device applications. “FDA believes the approach described in this [guidance](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM619220.pdf?ref=fdaweb.com) promotes the public health by helping patients have timely access to new medical devices meeting the applicable statutory standard for safety and effectiveness, including that the probable benefits outweigh the probable risks, based on the totality of the valid scientific evidence,” the document says.