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REGULATORY OUTLOOK

Return to Article: Building Quality into Device Clinical Trials, Part 2

When preparing a submission, organize the following information so that it is readily accessible for CDRH BIMO and investigators. The following information is critical for all PMA applications and for 510(k) applications that contain clinical research data and for the timely issue and completion of BIMO inspection assignments.

• Pertinent sponsor and site data.
     • Name and address of sponsor site with study information.
     • Names and addresses of any clinical research organizations or other contractors.
     • Names and addresses of all clinical investigators, including subinvestigators.
     • Number of subjects per site.
     • Names and addresses of reviewing IRBs.
• Nonclinical laboratory information (when relevant).
     • Names and addresses of all participating laboratories.
     • Final reports for all studies.
• Final clinical protocol, with all amendments, including CRFs and history of any changes, with corresponding date of the changes.
• Summary of safety and effectiveness data.
• List of primary and secondary endpoints and all acronyms.
• Line data (or tabulations of data) for each study subject, separated by site.
     • Data pertinent to primary and secondary endpoints.
     • Adverse effects.
     • Protocol deviations.
• Additional useful information.
     • Sample of Investigator Agreement.
     • Sample CRF.
     • Copies of informed-consent documents actually used at sites.
     • Monitoring SOPs—both general and study-specific.
     • Nonclinical study summaries.
     • Clinical study summaries.
     • Location of where clinical study records are maintained.