[Federal Register: December 28, 2004 (Volume 69, Number 248)]
[Rules and Regulations]               
[Page 77623-77624]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de04-5]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. 2004N-0530]

 
Medical Devices; Obstetrical and Gynecological Devices; 
Classification of the Assisted Reproduction Laser System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is classifying the 
assisted reproduction laser system into class II (special controls). 
The special control that will apply to the device is the guidance 
document entitled ``Class II Special Controls Guidance Document: 
Assisted Reproduction Laser Systems.'' The agency is classifying this 
device into class II (special controls) in order to provide a 
reasonable assurance of safety and effectiveness of the device. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
notice of availability of the guidance document that is the special 
control for this device.

DATES:  This rule is effective January 27, 2005. The classification was 
effective November 4, 2004.

FOR FURTHER INFORMATION CONTACT:  Michael Bailey, Center for Devices 
and Radiological Health (HFZ-400), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1180, ext. 130.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in 
commercial distribution before May 28, 1976, the date of enactment of 
the Medical Device Amendments of 1976 (the amendments), generally 
referred to as postamendments devices, are classified automatically by 
statute into class III without any FDA rulemaking process. These 
devices remain in class III and require premarket approval, unless and 
until the device is classified or reclassified into class I or II or 
FDA issues an order finding the device to be substantially equivalent, 
in accordance with section 513(i) of the act, to a predicate device 
that does not require premarket approval. The agency determines whether 
new devices are substantially equivalent to previously marketed devices 
by means of premarket notification procedures in section 510(k) of the 
act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA's 
regulations.
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act 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 document in the Federal Register announcing 
such classification (section 513(f)(2) of the act).
    In accordance with section 513(f)(1) of the act, FDA issued a 
document on August 10, 2004, classifying the Hamilton Thorne Zona 
Infrared Laser Optical System (ZILOS-tkr) into class III, because it 
was not substantially equivalent to a device that was introduced or 
delivered for introduction into interstate commerce for commercial 
distribution before May 28, 1976, or a device which was subsequently 
reclassified into class I or class II. On August 25, 2004, Hamilton 
Thorne Biosciences, Inc., submitted a petition requesting 
classification of this device under section 513(f)(2) of the act. The 
manufacturer recommended that the device be classified into class II 
(Ref. 1).
    In accordance with section 513(f)(2) of the act, FDA reviewed the 
petition in order to classify the device under the criteria for 
classification set forth in 513(a)(1) of the act. Devices are to be 
classified into class II if general controls, by themselves, are 
insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use. After review of the 
information submitted in the petition, FDA has determined that the 
device can be classified in class II with the establishment of special 
controls. FDA believes that class II special controls, in addition to 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    The device is assigned the generic name assisted reproduction laser 
system and it is identified as a device that images, targets, and 
controls the power and pulse duration of a laser beam used to ablate a 
small tangential hole in, or

[[Page 77624]]

to thin, the zona pellucida of an embryo for assisted hatching or other 
assisted reproduction procedures.
    The potential risks to health associated with the device are: (1) 
Damage to the embryo, (2) ineffective treatment, (3) hazards associated 
with electrical equipment, and (4) electromagnetic interference and 
electrostatic discharge hazards. The special controls guidance document 
entitled ``Class II Special Controls Document: Assisted Reproduction 
Laser Systems'' aids in mitigating the risks by recommending 
performance characteristics, safety testing, and appropriate labeling.
    Thus, in addition to the general controls of the act, an assisted 
reproduction laser system, is subject to the special controls guidance 
document. FDA believes that following the class II special controls 
guidance document generally addresses the risks to health identified in 
the previous paragraph. On November 4, 2004, FDA issued an order to the 
petitioner classifying the device as described previously into class II 
and is codifying this classification by adding 21 CFR 884.6200.
    Following the effective date of this final classification rule, any 
firm submitting a 510(k) (premarket notification) will need to address 
the issues covered in the special controls guidance. However, the firm 
need only show that its device meets the recommendations of the 
guidance or in some other way provides equivalent assurances of safety 
and effectiveness.
    Section 510(m) of the act provides that FDA may exempt a class II 
device from the premarket notification requirements under section 
510(k) of the act, if FDA determines that premarket notification is not 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For this type of device, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness; therefore, the 
device is not exempt from premarket notification requirements. Thus, 
persons who intend to market this type of device must submit to FDA a 
premarket notification, prior to marketing the device, which contains 
information about the device they intend to market.

II. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is not a significant regulatory action under the 
Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because classification of this device type into 
class II will relieve manufacturers of the device of the cost of 
complying with the premarket approval requirements of section 515 of 
the act (21 U.S.C. 360e), and may permit small potential competitors to 
enter the marketplace by lowering their costs, the agency certifies 
that the final rule will not have a significant impact on a substantial 
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $110 million. FDA does not expect this final rule to 
result in any 1-year expenditure that would meet or exceed this amount.

IV. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

V. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VI. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from Hamilton Thorne Biosciences, Inc., dated August 
25, 2004.

List of Subjects in 21 CFR Part 884

    Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
884 is amended as follows:

PART 884-OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
1. The authority citation for 21 CFR part 884 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 884.6200 is added to subpart G to read as follows:


Sec.  884.6200  Assisted reproduction laser system.

    (a) Identification. The assisted reproduction laser system is a 
device that 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.
    (b) Classification. Class II (special controls). The special 
control is FDA's guidance document entitled ``Class II Special Controls 
Guidance Document: Assisted Reproduction Laser Systems.'' See Sec.  
884.1(e) for the availability of this guidance document.

    Dated: December 15, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-28251 Filed 12-27-04; 8:45 am]

BILLING CODE 4160-01-S