{"data":{"id":"us/21-cfr-822.9","jurisdiction":"us","citation":"21 CFR 822.9","heading":"What must I include in my submission?","body":"Your submission must include the following:\n(a) Organizational/administrative information:\n(1) Your name and address;\n(2) Generic and trade names of your device;\n(3) Name and address of the contact person for the submission;\n(4) Premarket application/submission number and device identifiers for your device;\n(5) Table of contents identifying the page numbers for each section of the submission;\n(6) Description of the device (this may be incorporated by reference to the appropriate premarket application/submission);\n(7) Product codes and a list of all relevant model numbers; and\n(8) Indications for use and claims for the device;\n(b) Postmarket surveillance plan;\n(c) Designated person information;\n(1) Name, address, and telephone number; and\n(2) Experience and qualifications.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 822—POSTMARKET SURVEILLANCE","Subpart C—Postmarket Surveillance Plan"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"20df98505af79db4e33889309d8d9090690dac860d5cf1b3d66c43befc97fb3f","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-822.8","next":"us/21-cfr-822.10"},"notice":"GroundRules: Original legal text. Not legal advice."}