§822.9. What must I include in my submission?

21 C.F.R. § 822.9

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, and revision history

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

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

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

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