Federal Register / Vol. 69, No. 248 / Tuesday, December 28, 2004 / Rules and Regulations 77623

interested persons between 9 a.m. and 4 

p.m., Monday through Friday.

1. Gastroenterology and Urology Devices 

Panel of the Medical Devices Advisory 

Committee transcript, August 7, 1997.

2. Lewis J.H. et al., ‘‘A Way to Help Your 

Patients Who Use Vacuum Devices,’’

Contemporary Urology, vol. 3, No. 12: 15–24, 

1991.

3. Montague, D.K. et al., ‘‘Clinical 

Guidelines Panel on Erectile Dysfunction: 

Summary Report on the Treatment of Erectile 

Dsyfunction,’’ Journal of Urology, 156: 2007–

2011, 1996.

4. NIH Consensus Statement, ‘‘Impotence,’’

National Institutes of Health, vol. 10, No. 4, 

1992.

List of Subjects in 21 CFR Part 876

Medical devices.

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 876 is 

amended as follows:

PART 876—GASTROENTEROLOGYUROLOGY DEVICES

1. The authority citation for 21 CFR 

part 876 continues to read as follows:

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

360j, 360l, 371.

2. Section 876.1 is amended by 

adding paragraph (e) to read as follows:

§ 876.1 Scope.

* * * * *

(e) Guidance documents referenced in 

this part are available on the Internet at 

http://www.fda.gov/cdrh/guidance.html.

3. Section 876.5020 is added to 

subpart F to read as follows:

§ 876.5020 External penile rigidity devices.

(a) Identification. External penile 

rigidity devices are devices intended to 

create or maintain sufficient penile 

rigidity for sexual intercourse. External 

penile rigidity devices include vacuum 

pumps, constriction rings, and penile 

splints which are mechanical, powered, 

or pneumatic devices.

(b) Classification. Class II (special 

controls). The devices are exempt from 

the premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 876.9. The 

special control for these devices is the 

FDA guidance document entitled ‘‘Class 

II Special Controls Guidance Document: 

External Penile Rigidity Devices.’’ See 

§ 876.1(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. 04–28252 Filed 12–27–04; 8:45 am]

BILLING CODE 4160–01–S

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.

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 

77624 Federal Register / Vol. 69, No. 248 / Tuesday, December 28, 2004 / Rules and Regulations 

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.

■ 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

■ 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.

■ 2. Section 884.6200 is added to subpart 

G to read as follows:

§ 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 § 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