§ 29.11 - Contents of application.

(a) Each application for approval shall contain a complete written description, including operating instructions, of the analyzer or detector for which approval is requested together with a set of drawings and specifications (and lists thereof) showing full details of construction of the instrument and of the materials used. Drawings and specifications (and lists thereof) shall be submitted in duplicate.

(b) Drawings shall be titled, numbered, and dated; any revision dates shall be shown on the drawings, and the purpose of each revision being sought shall be shown on the drawing or described on an attachment to the drawing to which it applies.

(c) Each application for approval shall contain a proposed plan for quality control which meets the minimum requirements set forth in Subpart E of this part.

(d) Each application shall contain a statement that the analyzer or detector has been pretested by the applicant as prescribed in § 29.54, and shall include the results of such tests.

(e) Each application for approval shall contain a statement that the analyzer or detector and component parts submitted for approval are either (1) prototypes, or (2) made on regular production tooling, with no operation included which will not be incorporated in regular production processing.

(f) Where any form of radioactivity is employed in the analyzer or detector, the applicant shall submit:

(1) Evidence of compliance with all State regulations with respect to radiation and the use of radioactive materials; and

(2) Evidence of compliance with the requirements set forth in Title 10, Code of Federal Regulations.