Real-world Evidence

**Semantic type:** Idea or Concept

**Definition:** The clinical evidence derived from analysis of Real-World Data (RWD) regarding the usage and potential benefits or risks of a medical product. (FDA Guidance: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. August 31, 2017)

**Synonyms:** - RWE - Real World Evidence - Real World Evidence (RWE) - Real-World Evidence (RWE)