Is the patient accounting information in the literature sufficient to determine how the device performed?
Finally, when deciding if an article could be used to support marketing a new device, FDA and industry should consider contacting the author(s) of the research for additional information. For example, the study methods described in the literature are often very concise and do not include important details, such as the randomization method. Additional information about the study from the author(s) may provide details that strengthen the likelihood that the literature may be used to support the marketing application.
Related Questions
- What tests should be performed to determine the effectiveness of Detoxamin and how quickly are results felt by the patient and seen by the physician?
- Is the patient accounting information in the literature sufficient to determine how the device performed?
- What tests need to be performed in order to determine whether a patient has diabetes?
