Requirements and Obligations
It is important to note that any submission involving a significant risk device or study population that is not consistent with the current device labeling indication(s) (i.e., “off-label” use of marketed devices) will require an Investigational Device Exemption application (IDE) to the U.S. Food and Drug Administration (FDA) or local regulatory equivalent and approval by the agency prior to initiation of the study. Please visit www.fda.gov for further information.
In addition, the sponsor-investigator must comply with recognized ethical standards concerning publications and authorship, including the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (www.icmje.org), established by the International Committee of Medical Journal Editors (ICMJE). TMC recommends that you and your institution add your study to the FDA’s ClinicalTrials database (www.clinicaltrials.gov) or similar trial registry website in your country. Please note this may also be a prerequisite for publishing in select journals (e.g., the ICMJE).
For additional information about your responsibilities as a sponsor, please visit the following public websites: