The purpose of the International Medical Device Regulators Forum (IMDF) is to develop global regulatory device best practices. IMDF working groups post a technical document called “Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC).” This useful global template compares common elements and denotes regional differences. When submitting 510(k) and PMAs to the USFDA it is best to refer to the current version of the following guidance documents to ensure the content for each heading and the overall electronic format of the submission is sufficient to be accepted for review by the USFDA.
- Electronic Submission Template for Medical Device 510(k) Submissions Guidance for Industry and Food and Drug Administration Staff.
- Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff.
- eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff