---
kind: "section"
citation: "21 C.F.R. § 822.9"
title: "21"
number: "822.9"
heading: "What must I include in my submission?"
url: "https://uscodex.org/cfr/21/822.9"
---

# §822.9. What must I include in my submission?


Your submission must include the following:

- (a) **Organizational/administrative information—**
  - (1) Your name and address;
  - (2) Generic and trade names of your device;
  - (3) Name and address of the contact person for the submission;
  - (4) Premarket application/submission number and device identifiers for your device;
  - (5) Table of contents identifying the page numbers for each section of the submission;
  - (6) Description of the device (this may be incorporated by reference to the appropriate premarket application/submission);
  - (7) Product codes and a list of all relevant model numbers; and
  - (8) Indications for use and claims for the device;
- (b) Postmarket surveillance plan;
- (c) Designated person information;
  - (1) Name, address, and telephone number; and
  - (2) **Experience and qualifications.**

## Notes

### Amendments

[67 FR 38887, June 6, 2002, as amended at 78 FR 58823, Sept. 24, 2013]

### Authority

Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.

### Source

Source: 67 FR 38887, June 6, 2002, unless otherwise noted.

### Amendments

[67 FR 38887, June 6, 2002, as amended at 78 FR 58823, Sept. 24, 2013]