[Federal Register: December 28, 2004 (Volume 69, Number 248)]
[Notices]               
[Page 77756-77757]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de04-100]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0531]

 
Guidance for Industry and FDA Staff on Class II Special Controls 
Guidance Document: Assisted Reproduction Laser Systems; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Class II Special Controls 
Guidance Document: Assisted Reproduction Laser Systems.'' This guidance 
document describes a means by which assisted reproduction laser systems 
may comply with the requirement of special controls for class II 
devices. Elsewhere in this issue of the Federal Register, FDA is 
publishing a final rule to classify the assisted reproduction laser 
systems into class II (special controls). This guidance document is 
immediately in effect as the special control for assisted reproduction 
laser systems, but it remains subject to comment in accordance with the 
agency's good guidance practices (GGPs).

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Class II Special Controls 
Guidance Document: Assisted Reproduction Laser Systems'' to the 
Division of Small Manufacturers, International, and Consumer Assistance 
(HFZ-220), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-443-8818. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify comments with the 

docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Michael T. Bailey, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1180, ext. 130.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance describes a means by which assisted reproduction 
laser systems may comply with the requirement of special controls for 
class II devices. An assisted reproduction laser system images, 
targets, and controls the power and pulse duration of a laser beam used 
to ablate a small tangential hole in, or to thin, the zona pellucida of 
an embryo for assisted hatching or other assisted reproduction 
procedures. This guidance describes FDA's recommendations regarding 
performance characteristics, safety testing, and appropriate labeling.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule codifying the classification of assisted reproduction 
laser systems into class II (special controls) under section 513(f)(2) 
of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
360c(f)(2)). This guidance document will serve as the special control 
for assisted reproduction laser systems. Section 513(f)(2) of the act 
provides that any person who submits a premarket notification under 
section 510(k) of the act (21 U.S.C. 360(k)) for a device that has not 
previously been classified may, within 30 days after receiving an order 
classifying the device in class III under section 513(f)(1) of the act, 
request FDA to classify the device under the criteria set forth in 
section 513(a)(1) of the act. FDA shall, within 60 days of receiving 
such a request, classify the device by written order. This 
classification shall be the initial classification of the device. 
Within 30 days after the issuance of an order classifying the device, 
FDA must publish a notice in the Federal Register announcing such 
classification.
    Because of the timeframes established by section 513(f)(2) of the 
act, FDA has determined, under Sec.  10.115(g)(2) (21 CFR 
10.115(g)(2)), that it is not feasible to allow for public 
participation before issuing this guidance. Therefore, FDA is issuing 
this guidance document as a level 1 guidance document that is 
immediately in effect. FDA will consider any comments that are received 
in response to this notice to determine whether to amend the guidance 
document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (Sec.  10.115). The guidance represents the 
agency's current thinking on assisted reproduction laser systems. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statute 
and regulations.

III. Electronic Access

    To receive ``Class II Special Controls Guidance Document: Assisted 
Reproduction Laser Systems'' by fax, call the CDRH Facts-On-Demand 
system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. 
Press 1 to enter the system. At the second voice prompt, press 1 to 
order a document. Enter the

[[Page 77757]]

document number (1539) followed by the pound sign (). Follow 
the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so by using the Internet. CDRH maintains an entry on the Internet for 
easy access to information, including text, graphics, and files that 
may be downloaded to a personal computer with Internet access. Updated 
on a regular basis, the CDRH home page includes device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturer's assistance, information on video 
conferencing and electronic submissions, Mammography Matters, and other 
device-oriented information. The CDRH Web site may be accessed at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available on the Division of Dockets 
Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.


IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520) . 
The collections of information addressed in the guidance document have 
been approved by OMB in accordance with the PRA under the regulations 
governing premarket notification submissions (21 CFR part 807, subpart 
E, OMB control number 0910-0120) and the quality system regulation (21 
CFR part 820, OMB control number 0910-0073). The labeling provisions 
addressed in the guidance have been approved by OMB under OMB control 
number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: December 16, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-28254 Filed 12-27-04; 8:45 am]

BILLING CODE 4160-01-S