Get the free APPl,ICATXON FOR A VAR - fda

Apply, CATION FOR A VAR FROM 21 CFR 1040.11(c) FOR A LASER LIGHT SHOW, DISPLAY OR DEVICE DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION DOCKET NUh4BER NOTE. No

Note: It is advised that all photographs and all other documents presented in Application to FDA be certified by the photographer. If photography is required, see Appendix D for contact information for photography facility(s) for Certification for FDA clearance of photographs. For laser light show applications: — All photographs should be in color using an infrared or white Balance exposure standard approved by FDA for that event. — A complete list of standard colors and ratios for exposure must be submitted to FDA in order to have the same color intensity displayed for all Photographs. The same standard should be used for all photographs submitted. For approval. — The use of a camera should be accompanied by an IR sensor, which is standard procedure for all other applications submitted for approval To FDA. — A photograph showing the entire stage of the show or display must not be Submitted as an individual item. 3. For presentations, the application must include a complete description for the. Participants including: a. Name and address of each participant; b. Date and. Time of the event; c. Description of lighting/display systems employed; and d. Names and. addresses of all vendors, vendors' agents, and all other individuals or entities Who will be present at the event. 4. The individual or entity(s) conducting the show or display is required to. Provide FDA identification on the form. 5. The proposed design and size of the display must be consistent with. Published standards and guidelines. 6. A photograph or other clear and detailed illustration(s) must appear on the. Application. 7. The proposed exposure or exposure ratio for each test is set forth in Section. C3C, Section F, Article III, Subpart C. c. Applicants desiring exemption from the provisions of Section 3 of the. Laser Light Show The following applications requesting exemption from Section 3 of the Laser Light Show will not be considered pursuant to Section 3(a)(9) of the Act. 1. Applications for exemption from Section 3 of the Laser Light Show. for exhibition of a laser light display only (does not include any or all Display areas). 2.

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