1. Form FDA 3601: Medical Device User Fee Cover Sheet (MDUFC sheet)
2. FDA Form 3514- CDRH Premarket Review Submission Cover Sheet: This document includes basic administrative and device information.
3. 510(k) Cover Letter: This document provides a brief idea about the purpose of the submission, device, manufacturer and the U.S agent (if any).
4. FDA Form 3881: Indications for Use Statement
5. 510(k) Summary or 510(k) Statement: This includes a summary of the device undergoing the 510(k) clearance.
6. Truthful & Accuracy Statement: This is to certify that the 510(k) submission contents are truthful and accurate and no information omitted.
7. Class III Summary and Certification: If the proposed device is a Class III exempt from PMA, otherwise, this can be marked as not applicable.
8. Financial Certification or Disclosure Statement: This is applicable only if clinical studies were conducted
9. Declarations of Conformity and Summary Reports: Lists the voluntary consensus standards used and includes DOC to such standards.
10. Device Description: This document includes the description of the device design requirements and performance specifications.
11. Executive Summary: a brief description of the device & comparison table with the predicate device identified.
12. Substantial Equivalence Discussion: Detailed comparison between the proposed device and the predicate device chosen.
13. Proposed Labeling: Is discussed in detail to comply with 21 CFR 807.87(e) for general medical devices and 21 CFR 809.10 for IVD’s
14. Sterilization and Shelf Life: This document provides details regarding the sterilization and shelf life claim being made.
15. Biocompatibility: This document is applicable if the proposed device comes into direct or indirect contact with the human body tissue.
16. Software: This includes the documentation for any software used in the proposed device
17. Electromagnetic Compatibility and Electrical Safety- If the proposed device is powered electrically, in which case the EMC must be evaluated.
18. Performance Testing – Bench: This document included details of the bench tests performed to evaluate the efficiency of the proposed device.
19. Performance Testing – Animal: This document included details of the animal testing performed to evaluate the efficiency of the proposed device.
20. Performance Testing – Clinical: This document included details of the clinical studies performed to evaluate the efficiency of the proposed device.

The completed FDA 510(k) file is submitted in electronic format as an e-copy to the FDA. The submission package is sent to the CDRH through registered mail or commercial delivery service.