§ 822.9. What must I include in my submission?

128 words·~1 min read·/us/cfr/t21/s§ 822.9·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

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