Final USFDA Guidance on Real World Evidence and Medical Devices

Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Real World Evidence (RWE) can exist across a wide spectrum, ranging from observational studies within an existing dataset to studies that incorporate planned interventions with or without randomization at the point of care. Because of the rapidly advancing methodology for generating and interpreting RWD, this guidance will not elaborate on the methodological approaches that can be used. However, when reviewing the use of RWE to support a regulatory decision, FDA will rely on scientifically robust methods and approaches to determine whether submitted RWE is of sufficient quality to support a particular regulatory decision.

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