What Clinical Data Sources Can Be Used Except The Source From Literature Of Comparable Medical Devices?

Other than clinical data from literature, the clinical data of comparable devices also include the data source from clinical experience and clinical trials. The clinical experience data includes completed clinical research data sets, adverse event data sets, and clinical risk-related corrective action data sets. The adverse event data set can be acquired from post-market complaints and adverse events published by regulatory agencies.
The collection, analysis and evaluation of clinical data of comparable medical devices should include: Confirming whether the safety and effectiveness of the chosen comparable medical devices have been clinically recognized and whether its risks and benefits are acceptable; Fully identify the risks of clinical use of the comparable medical device(s), which can provide information for the risk-benefit analysis of the device in question; Confirm the residual risks of non-clinical research through clinical data; Provide clinical data for the evaluation of the test results of some non-clinical research (such as bench tests).
In addition, the administrative counterpart also needs to confirm whether the safety and effectiveness of chosen comparable medical device(s) is widely used and recognized. And whether the literature search strategy is appropriate, as well as it can ensure the comprehensiveness of the search.