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# Guidance on Real-World Evidence in Device Decisions
- URL: https://www.fdaweb.com/guidance-on-real-world-evidence-in-device-decisions/
- Published: 2017-08-30T12:00:00.000Z
- Updated: 2026-09-14T22:45:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139503

FDA will publish 8/31 a guidance, *Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices*, to clarify how the agency evaluates real-world data to determine if they are sufficiently relevant and reliable to generate the types of real-world evidence that can be used in FDA regulatory decision-making for medical devices. A *Federal Register* [notice](https://www.federalregister.gov/documents/2017/08/31/2017-18469/guidance-use-of-real-world-evidence-to-support-regulatory-decision-making-for-medical-devices?ref=fdaweb.com) says that because of its nature, the relevance and reliability of real-world data can vary across sources. And, it says, there are many types of regulatory decisions with varying levels of evidentiary needs.

“FDA’s evidentiary standards for regulatory decision-making are not changing,” the notice says. “FDA encourages the use of real-world evidence where appropriate, and will evaluate whether the evidence is of sufficient relevance and reliability to address the specific regulatory decision being considered.”

The agency says the guidance should be used to complement, but not supersede, other device-specific and good clinical practice guidance documents. FDA says it considered comments received on the draft guidance that was published 7/27/16 and then made revisions in response to the comments.