Form Fda 3147 PDF Details

Navigating the complexities of regulatory compliance for laser light shows, displays, or devices involves numerous considerations, one of which is the necessity to apply for a variance from specific federal regulations when such activities deviate from established safety standards. The FDA Form 3147 serves as a critical document in this regard, facilitating the application process for a variance from 21 CFR 1040.11(c), thereby addressing the need for operating beyond the normative bounds of laser radiation exposure to the public. This form, approved under OMB No. 0910-0025, is a detailed submission that requires applicants to thoroughly justify their request to deviate from standard compliance in terms of design or use of laser products. It encompasses a myriad of information, from basic identification details of the applying entity to a comprehensive description of the product and the specific nature of the requested variance. The instructions outline the need to check applicable boxes, properly fill in the requested details, and accompany the form submission with a variance package cover sheet and a laser light show report, all aimed at ensuring the responsible deployment of enhanced laser effects in entertainment or educational settings. Additionally, the form delves into the alternative means of radiation protection that the applicant must provide to compensate for the exceeded emission levels, ensuring safety despite deviation from the norm. This process is tightly regulated to guarantee that any increase in laser power for visual effects does not compromise public health and safety, reflecting the Food and Drug Administration’s commitment to both innovation and well-being.

QuestionAnswer
Form NameForm Fda 3147
Form Length4 pages
Fillable?No
Fillable fields0
Avg. time to fill out1 min
Other namesfda3147 c, variance c device download, fda3147 c form, fda 3147

Form Preview Example

 

 

 

 

 

 

APPLICATION FOR A VARIANCE

 

Form Approved: OMB No. 0910-0025

 

 

 

 

 

 

 

FROM 21 CFR 1040.11(C) FOR A

 

Expiration Date: August 31, 2023

 

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

See Page 4 for PRA Statement.

 

 

Food and Drug Administration

LASER LIGHT SHOW, DISPLAY,

 

 

 

 

 

 

 

DOCKET NUMBER

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OR DEVICE

 

 

 

 

 

 

 

NOTE: No laser light show, projection system, or device may vary from compliance with 21 CFR 1040.11(c) in design or use without the approval of this

 

 

application in accordance with 21 CFR 1010.4.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

INSTRUCTIONS

 

 

 

 

 

 

 

 

1. Check all applicable boxes, enter the requested information, and sign this form. 4. For more information regarding this form and to find digital copies of the CDRH Variance

 

 

2. Enter docket number if assigned.

 

 

 

cover letter checklist and the laser light show report form, visit our website: https://www.fda.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3. Submit this form, with the CDRH Variance Package Cover Sheet, and a laser

gov/radiation-emitting-products/home-business-and-entertainment-products/laser-light-shows.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

light show report, by email to: RadHealthCustomerService@fda.hhs.gov.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1. NAME OF COMPANY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2. ADDRESS OF COMPANY (Include ZIP Code)(If P.O. Box is used, include actual street address also.)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3. NAME AND TITLE OF RESPONSIBLE PERSON

 

 

 

 

 

 

 

 

 

 

4.a. TELEPHONE NO. (Include area code)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4.b. EMAIL ADDRESS

 

 

 

 

 

 

 

 

 

 

5. DATE OF SUBMISSION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6. THE APPLICANT REQUESTS THE VARIANCE TO BE IN EFFECT FOR A PERIOD OF

 

 

YEARS FROM THE DATE OF ISSUE. (In

 

 

general, the Agency will approve a variance for only two years. If a longer period is requested, a justification must be attached as part of the application.)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7.

 

 

 

 

PRODUCT DESCRIPTION AND USE

 

 

 

 

 

 

 

 

a. LIST NAME AND/OR MODEL NUMBER(S) FOR THE LASER LIGHT SHOW(S) AND PROJECTOR(S)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

b. PRODUCT FOR WHICH A VARIANCE IS REQUESTED

 

 

 

 

f. PRODUCT IS INTENDED TO BE USED AT ANY ONE LOCATION

 

A laser display device

 

 

 

 

More than 15 days

 

 

 

 

 

 

 

 

A projector for a laser light show

 

 

 

 

More than 5 but not more than 15 days

 

A laser light show

 

 

 

 

Less than 5 days

 

 

 

 

 

 

 

 

Other (Specify)

 

 

 

 

 

g. TOUR IS INTENDED TO RUN FOR

 

 

 

 

 

c. PROJECTORS ARE INTENDED FOR SALE, LEASE, OR LOAN TO

 

More than 6 months

 

 

 

 

 

 

 

 

OTHER LASER LIGHT SHOW PRODUCERS

 

 

 

 

1 - 6 months

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

d. PRODUCT IS INTENDED FOR USE IN A

 

 

 

 

Less than one month

 

 

 

 

 

 

 

 

Planetarium or other dome projection structure

 

 

 

 

Not applicable (Not a tour)

 

 

 

 

 

Theater

 

 

 

 

Other (Specify)

 

 

 

 

 

 

 

 

 

Hotel/motel ballroom or meeting room

 

 

 

 

h. PRODUCT UTILIZES THE FOLLOWING LASER EFFECTS

 

Store displays

 

 

 

 

Front screen projections

 

 

 

 

 

Trade show or convention

 

 

 

 

Rear screen projections

 

 

 

 

 

Discotheque or night club

 

 

 

 

Holographic displays

 

 

 

 

 

 

 

 

Pavilion

 

 

 

 

Multiple reflection/diffraction effects

 

Indoor arena

 

 

 

 

Audience scanning (Also includes scanning any accessible

 

Outdoor arena

 

 

 

 

uncontrolled areas)

 

 

 

 

 

 

 

 

Museum

 

 

 

 

Reflections from stationary mirrors or mirrored

 

Outdoor unenclosed area

 

 

 

 

surfaces (Beam Matrices)

 

 

 

 

 

Other (Specify)

 

 

 

 

 

Stationary irradiation of rotating mirror balls, etc.

 

e. PRODUCT IS INTENDED TO BE USED

 

 

 

 

Scanning irradiation of rotating mirror balls, etc.

 

At only one (Fixed) location

 

 

 

 

Fiber optic projections

 

 

 

 

 

At a variety of (Tour) locations

 

 

 

 

Fog, smoke, or other scattering enhancement effects

 

Other (Specify)

 

 

 

 

Other (Specify)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8.

 

 

 

 

LASER RADIATION LEVELS

 

 

 

 

 

 

 

 

LASER MEDIUM (Ar, He-Ne, etc.)

 

 

WAVE LENGTHS (nm)

 

 

 

 

 

PEAK POWER (watts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

9. IF ANY LASER RADIATION IS PULSED OR SCANNED, GIVE THE PULSE DURATION AND RATE AND SCANNING FREQUENCY AND AMPLITUDE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10. REASON FOR REQUESTING VARIANCE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Compliance with the limits of 21 CFR 1040.11(c) would restrict the intended use of the product because compliance would

 

limit the output power to the extent that the desired effects would not be sufficiently visible

 

 

 

 

 

 

 

 

Other or additional explanation (Specify)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FORM FDA 3147 (12/20)

PREVIOUS EDITION IS OBSOLETE

 

 

 

PAGE 1 OF 4 PAGES

PSC Publishing Services (301) 443-6740 EF

11. MANNER IN WHICH IT IS PROPOSED TO DEVIATE FROM THE REQUIREMENTS OF THE APPLICABLE STANDARD

It is proposed to deviate from the provisions of 21 CFR 1040.11(c) in that the accessible emission level would exceed the accessible emission limits specified in 21 CFR 1040.11(c).

It is proposed to deviate from the provisions of 21 CFR 1040.11(c) as follows:

12. ADVANTAGES TO BE DERIVED FROM SUCH DEVIATION

Laser light shows and displays are accepted popular media in entertainment and the arts. Use of power levels in excess of the limits imposed by 21 CFR 1040.11(c) is necessary to achieve the required effects in these media.

Other or additional advantages (describe and explain).

13.EXPLAIN THE ALTERNATE MEANS OF RADIATION PROTECTION TO BE PROVIDED. (Check as many boxes as apply. In item 14 "Remarks," justify any boxes not checked, using additional sheets as necessary. State any other means of radiation protection that will be used.)

a. All laser products, systems, shows, and projectors will be certified to comply with 21 CFR 1040.10 and the conditions of this variance and will be reported as required by 21 CFR 1002.10 AND 1002.11 using the reporting guides provided for such purpose. These actions will be accomplished prior to any introduction into commerce.

b. Effects not specifically indicated in this variance application will not be performed. No other effects will be added until an amendment to the variance has been obtained and the required reports or supplements, as applicable, have been submitted.

c. Scanning, projection, or reflection of laser and collateral radiation (Light show radiation) into audience or other accessible uncontrolled areas will not be permitted except for diffuse reflections produced by the atmosphere, added atmospheric scattering media, and target screens.

d. Laser radiation levels in excess of the limits of Class I will not be permitted at any point less than 3.0 meters above any surface upon which persons other than operators, performers, or employees are permitted to stand or 2.5 meters below or in lateral separation from any place where such persons are permitted to be. Operators, performers, and employees will not be required or allowed to view radiation above the limits of Class I or be exposed to radiation above the limits specified in 21 CFR 1040.11(c).

e. Any product which relies on scanning to meet access, exposure, or product class limits will incorporate a scanning safeguard system which directly senses scanner motion and which will react fast enough to preclude exceeding the applicable limit.

f. All laser light shows shall be under the direct and personal control of trained, competent operator(s). The operator(s) will:

(1)Be an employee of the variance holder who will be responsible for the training and the conduct of the operator;

(2)Be located where all beam paths can be directly observed at all times; and

(3)Immediately terminate the emission of light show radiation in the event of any unsafe condition; or, for outdoor shows, upon request by any air traffic control officials.

g. The maximum laser projector output power will not exceed the level required to obtain the intended effects.

h. The projection system (i.e., the projector and all other components used to produce the lighting effects) will be securely mounted or immobilized to prevent unintended movement or misalignment. Beam masking will be provided as an inherent part of the system design to prevent overfilling of screens, beam stops, targets, etc.

i. Laser projectors will not be delivered to any other party under an agreement of sale, lease, or loan unless and until the recipient demonstrates that they have a variance in effect at the time of delivery that permits them to produce laser light shows incorporating such projector(s).

j. In addition to the requirements of 21 CFR 1040.10(h), the manufacturer of laser projectors/systems will provide to parties who purchase, lease,

or borrow the equipment, adequate users’ instructions for safe installation and operation which explain the responsibility of the recipient as an independent light show manufacturer to submit the required reports and apply for and obtain a variance from CDRH prior to introduction into commerce of any laser light shows.

k. The requirements of 21 CFR 1002.30(a)(1) and (2) will be accomplished through the use of written procedures for setup, alignment, testing, and performance of each show. These procedures will be in sufficient detail to ensure compliance with 21 CFR 1040.10, the conditions of this variance, and the control of access to radiation areas using the procedures described in the ANSIZ136.1 standard for the safe use of lasers (Laser Institute of America (LIA), 13501 Ingenuity Drive, Suite 128, Orlando, FL 32826) or any other equivalent user consensus standard and, where applicable, state or local requirements. Laser radiation areas which can contain radiation levels above the limits specified in 21 CFR 1040.11(c) will be clearly identified by the posting of warning signs and/or restricting access through physical means (such as pressure switches, photo cells, barriers, guards, etc.). These requirements apply to temporary areas (such as during set up and alignment procedures) and to final or permanent areas. The variance holder will retain the records of these procedures and the results of all tests as required by 21 CFR 1002.31. A copy of the variance application, the approval letter, current procedures, and records relating to each particular show will be with the operator or other responsible individual and will be made available for inspection by FDA and other responsible authorities.

FORM FDA 3147 (12/20)

PAGE 2 OF 4 PAGES

l. Advance written notification will be made as early as possible to appropriate federal, state, and local authorities providing show itinerary with dates and locations clearly and completely identified, and a basic description of the proposed effects including a statement of the maximum power output intended. Such notifications will be made, but not necessarily be limited, to:

(1)Information about particular laser shows will be maintained in the records for the show and will be provided upon request to the Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health, Division of Radiological Health, Magnetic Resonance Branch, Silver Spring, MD 20993. This information will provide the initial and closing dates for fixed installations and the itinerary for mobile shows. In addition, unless all aspects of each show have been reported and accession numbers clearly referenced, each notice will include detailed descriptions of each show and a listing of all effects to be performed in sufficient detail to confirm compliance with the regulations and this variance.

(2)The Federal Aviation Administration (FAA) for any projections into open airspace at any time (i.e., including set up, alignment, rehearsals, performances, etc.). If the FAA objects to any laser effects, the objections will be resolved and any conditions requested by FAA will be adhered to. If these conditions cannot be met, the objectionable effects will be deleted from the show.

(3)State and local radiation control offices/agencies for all shows to be performed within their jurisdictions. All requirements of state and local law will be satisfied and any objections raised by local authorities will be resolved or the effects deleted. (A list of federal and state offices is available from the Center for Devices and Radiological Health upon request.)

14.REMARKS

15. IF THE SUBMITTER IS DIFFERENT FROM THE APPLICANT, PLEASE ENTER THE FOLLOWING:

SUBMITTER NAME

ADDRESS

CITY

STATE

ZIP CODE

COUNTRY, IF NOT US

PHONE NUMBER

EMAIL ADDRESS

CERTIFICATION

I CERTIFY that all of the above information and statements are true, complete, and correct to the best of my knowledge and acknowledge that my variance application may be denied or my variance may be revoked if this application is found to be false, misleading or incorrect in any material way. I have submitted and will submit all reports required by 21 CFR 1002.10 and 1002.11 on the laser equipment and show(s). I further understand that I may be required by regulation or by the Director, Center for Devices and Radiological Health, to supply such other information as may be necessary to evaluate and act on this application.

16. APPLICANT'S SIGNATURE

17.NAME (Type or Print)

18. TITLE

FORM FDA 3147 (12/20)

PAGE 3 OF 4 PAGES

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 0.5 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Operations

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of

information unless it displays a currently valid OMB number.”

FORM FDA 3147 (12/20)

PAGE 4 OF 4 PAGES

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fda 3147 completion process explained (stage 1)

2. Just after filling in the last part, go on to the subsequent stage and complete the essential particulars in these fields - A projector for a laser light show, A laser light show, Other Specify, More than but not more than days, Less than days, g TOUR IS INTENDED TO RUN FOR, PROJECTORS ARE INTENDED FOR SALE, d PRODUCT IS INTENDED FOR USE IN A, Planetarium or other dome, Theater, More than months, months, Less than one month, Not applicable Not a tour, and Other Specify.

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3. Completing IF ANY LASER RADIATION IS PULSED, REASON FOR REQUESTING VARIANCE, Compliance with the limits of CFR, Other or additional explanation, FORM FDA, PREVIOUS EDITION IS OBSOLETE, PAGE OF PAGES, and PSC Publishing Services is essential for the next step, make sure to fill them out in their entirety. Don't miss any details!

IF ANY LASER RADIATION IS PULSED, Compliance with the limits of  CFR, and PREVIOUS EDITION IS OBSOLETE of fda 3147

4. This next section requires some additional information. Ensure you complete all the necessary fields - MANNER IN WHICH IT IS PROPOSED TO, It is proposed to deviate from the, It is proposed to deviate from the, ADVANTAGES TO BE DERIVED FROM, Laser light shows and displays are, Other or additional advantages, EXPLAIN THE ALTERNATE MEANS OF, any boxes not checked using, All laser products systems shows, Effects not specifically indicated, and Scanning projection or reflection - to proceed further in your process!

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5. Since you reach the end of the form, there are actually a few more requirements that have to be met. Specifically, Laser radiation levels in excess, Any product which relies on, All laser light shows shall be, Be an employee of the variance, Be located where all beam paths, Immediately terminate the, by any air traffic control, The maximum laser projector output, The projection system ie the, Laser projectors will not be, In addition to the requirements of, and The requirements of CFR a and should be filled out.

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