§ 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.