The clinical investigations section of the PMA application should include the study protocols, safety and effectiveness data, adverse reactions and complications, device failures and replacements, patient information, tabulations of data from all individual subjects, results of statistical analyses, and any other pertinent information from the clinical investigations. A clinical study that is considered a significant-risk clinical study and conducted under an Investigational Device Exemption (IDE) must be identified as such (21 CFR 812).
 
 
The FDA will accept a PMA based solely on foreign clinical data if the study was conducted under an IDE or conducted in conformance with the “Declaration of Helsinki”; if the foreign data are applicable to the U.S. population and medical practice; if the studies have been performed by clinical investigators with recognized competence in their field; and if the data may be considered valid either without the need for an on site inspection by the FDA or if necessary the FDA is able to validate the data through an on site inspection.
 
 
It is important to consult all applicable FDA Guidance documents and industry standards before proceeding with your clinical investigation. 
 
 
GEMAR can help you to identify the relevant standards and guidance documents; interface with the FDA during pre-sub and IDE meetings (especially important if you are using entirely foreign clinical data), and ensure that the study design, study conduct, data analyses, presentation and conclusions are scientifically sound and presented in a well organized format.