For studies conducted outside of the u.s., the device risk analysis and assessment are described in the Investigator's Brochure (IB)
This is further explained below.
Generally, The Investigator's Brochure (IB), which is kept up to date by a drug developer or investigator, is a thorough compilation of clinical and nonclinical data on the investigational product (drug, supplement, device, or other product) that contains the body of knowledge about the investigational product obtained before the study began.
In conclusion, The device risk analysis and evaluation are given in the investigator's brochure for trials that were carried out in countries other than the United States (IB)
Read more about Investigator's Brochure (IB)
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