Fla. Admin. Code Ann. R. 64E-4.001 - Registration and Laser Radiation Requirements
(1) Except as otherwise specifically exempted
under these rules, all persons who receive, possess, acquire, transfer, own,
manufacture, or use lasers which emit or may emit laser radiation shall
register within 30 days after acquisition of a laser product and comply with
these rules. Nothing in these rules shall be interpreted as limiting the
intentional exposure of patients to laser radiation for the purpose of
treatment or use commensurate with the licensed practitioner's use of the
healing arts.
(2) A separate
registration is required for each location with a laser device, on DH Form 1605
(09/14), "Laser Device Registration Form," incorporated by reference and
available at
https://www.flrules.org/Gateway/reference.asp?No=Ref-04839
or www.FloridaHealth.gov/radiation.
Laser manufacturers must register on DH Form 1604 (09/14), "Manufacturer's
Laser Device Registration Form," incorporated by reference and available at
https://www.flrules.org/Gateway/reference.asp?No=Ref-04838
or www.FloridaHealth.gov/radiation.
Subsequent registrations for each facility or mobile laser facility are
required whenever additional laser devices are installed or previously
registered laser devices are disposed of, altered, destroyed or moved to new
locations. Subsequent registrations for each manufacturer are required only
when the description of the laser devices manufactured by the manufacturer
changes.
(3)
(a) Laser products certified by a
manufacturer to be compliant with the Federal laser product performance
standard of 21 C.F.R. Part 1040 in effect at the date of manufacture shall be
maintained in compliance with such requirements. Certified laser products which
have been modified shall comply with these rules.
(b) Uncertified lasers shall meet the
requirements of these rules.
(4) If any conflict arises between the
requirements of these rules and the federal laser product performance standard,
the requirements of the federal standard shall apply.
(5) Except as provided in this rule section,
the contents of this rule chapter are contained in the Department of Health
publication "Laser Radiation Requirements" (December 15, 2016, edition)
incorporated by reference and available at
http://www.flrules.org/Gateway/reference.asp?No=Ref-07888.
(6) Title
21 C.F.R. sections
1040.10 and
1040.11
(April 1, 2013, edition) are incorporated by reference and available at
http://www.flrules.org/Gateway/reference.asp?No=Ref-07889.
(7) The publication ANSI Z136.1-2014,
"American National Standard for Safe Use of Lasers" (ANSI), is incorporated by
reference and available at www.lia.org. This publication may be examined and
inspected at the Florida Department of Health, Bureau of Radiation Control,
4042 Bald Cypress Way, Suite 210, Tallahassee, Florida 32399-1741, and the
Florida Department of State, Room 701, The Capitol, Tallahassee, Florida
32399-0250. The agency has determined that posting the publication on the
internet for purposes of public inspection and examination would constitute a
violation of federal copyright law.
(8) Completed registration forms or other
correspondence or reports required by Chapter 64E-4, F.A.C., to be sent in
writing to the Department can be mailed to Florida Department of Health, Bureau
of Radiation Control, 4052 Bald Cypress Way, Bin #C-21, Tallahassee, Florida
32399-1741; faxed to (850)487-0435; or scanned and emailed to
RadiationControl@FlHealth.gov in PDF, JPG or TIF format.
Notes
Rulemaking Authority 501.122(2) FS. Law Implemented 501.122(2) FS.
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