Form Fda 3147 - Application For A Variance Page 2
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411. 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.)
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
a.
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.
Effects not specifically indicated in this variance application will not be performed. No other effects will be added until an amendment to the
b.
variance has been obtained and the required reports or supplements, as applicable, have been submitted.
Scanning, projection, or reflection of laser and collateral radiation (Light show radiation) into audience or other accessible uncontrolled areas will
c.
not be permitted except for diffuse reflections produced by the atmosphere, added atmospheric scattering media, and target screens.
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
d.
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).
In addition to the requirements of 21 CFR 1040.10(h), the manufacturer of laser projectors/systems will provide to parties who purchase, lease,
j.
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 (8/16)
PAGE 2 OF 4 PAGES
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