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 numbers 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.