Federal Register / Vol. 72, No. 78 / Tuesday April 24, 2007 / Rules and Regulations 20225 

I b Arkansas b Indiana b Missouri b Oklahoma b Virgin Islands 

S b California b Iowa b Montana b Oregon b Virginia 

D b Colorado b Kansas b Nebraska b Pennsylvania b Washington 

I b Connecticut b Kentucky b Nevada b Puerto Rico b West Virginia 

C b Delaware b Louisiana b New Hampshire b Rhode Island b Wisconsin 

T b District of Columbia b Maine b New Jersey b South Carolina b Wyoming 

I b Florida b Maryland b New Mexico b South Dakota 

O b Georgia b Massachusetts b New York b Tennessee 

N 

* * * * * 

■ 3. Form BDW (referenced in 

§ 249.501a) is amended by: 

■ a. In the Explanation of Terms section, 

revising ‘‘The term JURISDICTION 

means a state, the District of Columbia, 

the Commonwealth of Puerto Rico, or 

any subdivision or regulatory body 

thereof.’’ to read ‘‘The term 

JURISDICTION means a state, the 

District of Columbia, the 

Commonwealth of Puerto Rico, the U.S. 

Virgin Islands, or any subdivision or 

regulatory body thereof.’’; and 

■ b. In Item 3, revising the SRO and 

Jurisdiction tables. 

The revision reads as follows: 

Form BDW 

* * * * * 

3. * * * 

S b b b b b b b b b b b blll 

R 

O 

AMEX BSE CBOE CHX NSX NASD NQX NYSE PHLX ARCA ISE OTHER 

(specify) 

J b Alabama b Hawaii b Michigan b North Carolina b Texas 

U b Alaska b Idaho b Minnesota b North Dakota b Utah 

R b Arizona b Illinois b Mississippi b Ohio b Vermont 

I b Arkansas b Indiana b Missouri b Oklahoma b Virgin Islands 

S b California b Iowa b Montana b Oregon b Virginia 

D b Colorado b Kansas b Nebraska b Pennsylvania b Washington 

I b Connecticut b Kentucky b Nevada b Puerto Rico b West Virginia 

C b Delaware b Louisiana b New Hampshire b Rhode Island b Wisconsin 

T b District of Columbia b Maine b New Jersey b South Carolina b Wyoming 

I b Florida b Maryland b New Mexico b South Dakota 

O b Georgia b Massachusetts b New York b Tennessee 

N 

* * * * * 

By the Commission. 

Dated: April 19, 2007. 

Florence E. Harmon, 

Deputy Secretary. 

[FR Doc. E7–7746 Filed 4–23–07; 8:45 am] 

BILLING CODE 8010–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 884 

[Docket No. 2007N–0120] 

Medical Devices; Obstetrical and 

Gynecological Devices; Classification 

of Computerized Labor Monitoring 

System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying the 

computerized labor monitoring systems 

into class II (special controls). 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of a guidance document 

entitled, ‘‘Guidance for Industry and 

FDA Staff; Class II Special Controls 

Guidance Document: Computerized 

Labor Monitoring Systems,’’ which will 

serve as the special controls for these 

devices. The agency is classifying these 

devices into class II (special controls) in 

order to provide a reasonable assurance 

of safety and effectiveness of these 

devices. 

DATES: This rule is effective May 24, 

2007. The classification was effective 

January 30, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Glenn Bell, Center for Devices and 

Radiological Health (HFZ–470), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–4100. 

SUPPLEMENTARY INFORMATION: 

I. What is The Background Of This 

Rulemaking? 

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 the device is 

classified or reclassified into class I or 

class 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 predicate 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 

type. Within 30 days after the issuance 

of an order classifying the device, FDA 

must publish a notice 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 an order on October 

5, 2006, classifying the Computerized 


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20226 Federal Register / Vol. 72, No. 78 / Tuesday April 24, 2007 / Rules and Regulations 

Labor Monitoring System in 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 that was subsequently 

reclassified into class I or class II. 

Barnev Ltd. submitted a petition dated 

October 15, 2006, requesting 

classification of the Computerized Labor 

Monitoring System 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 determined that 

computerized labor monitoring systems 

can be classified into class II with the 

establishment of special controls. FDA 

believes that these special controls, in 

addition to general controls, are 

adequate to provide reasonable 

assurance of the safety and effectiveness 

of the device. 

The device is assigned the generic 

name ‘‘Computerized Labor Monitoring 

System.’’ It is identified as a system 

intended to continuously measure 

cervical dilation and fetal head descent 

and provide a display that indicates the 

progress of labor. The computerized 

labor monitoring system includes a 

monitor and ultrasound transducers. 

Ultrasound transducers are placed on 

the maternal abdomen and cervix and 

on the fetal scalp to provide the matrix 

of measurements used to produce the 

display. 

FDA has identified the risks to health 

associated with this type of device as—

A. Patient Injury—tissue injury or 

bleeding to baby or mother 

B. Electrical Hazards—electrical 

shock 

C. Acoustical (ultrasound) Tissue 

Damage—acoustical heating of tissue 

due to ultrasound 

D. Electromagnetic Interference and 

Electrostatic Discharge Hazards—

electromagnetic emissions interfering 

with other medical devices or 

electromagnetic susceptibility causing 

the device to function improperly due to 

emissions of other devices 

E. Mismanagement of Patient—

unattended birth or improper clinical 

decisions based on device output 

information 

F. Adverse Tissue Reaction—adverse 

tissue reaction to bio-incompatible 

materials 

G. Infection - bacterial, viral, or fungal 

infection of baby or mother 

FDA believes that the class II special 

controls guidance document will aid in 

mitigating the potential risks to health 

as described in table 1 of this document. 

TABLE 1.—RISKS TO HEALTH AND MITIGATION MEASURES

Identified Risk Mitigation Measures 

Patient Injury Nonclinical Analysis and Testing 

Software 

Clinical Information 

Labeling 

Electrical Hazards Nonclinical Analysis and Testing 

Electrical Safety 

Labeling 

Acoustical (ultrasound) Tissue Damage Nonclinical Analysis and Testing 

Ultrasound Safety 

Labeling 

Electromagnetic Interference and Electrostatic Discharge Hazards Electromagnetic Compatibility 

Labeling 

Mismanagement of Patient Nonclinical Analysis and Testing 

Software 

Clinical Information 

Labeling 

Adverse Tissue Reaction Biocompatibility 

Infection Sterilization Information 

FDA believes that the special controls, 

in addition to general controls, address 

the risks to health identified previously 

and provide reasonable assurances of 

the safety and effectiveness of the 

device type. Thus, on January 30, 2007, 

FDA issued an order to the petitioner 

classifying the device into class II. FDA 

is codifying this classification at 21 CFR 

884.2800. 

Following the effective date of the 

final classification rule, manufacturers 

will need to address the issues covered 

in the special controls guidance. 

However, the manufacturer need only 

show that its device meets the 

recommendations of the guidance or in 

some other way provides equivalent 

assurance of safety and effectiveness. 

Section 510(m) of the act provides 

that FDA may exempt a class II device 

from the premarket notification 

requirement under 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 of the device 

and, therefore, the type of device is not 

exempt from premarket notification 

requirements. 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 computerized 


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Federal Register / Vol. 72, No. 78 / Tuesday April 24, 2007 / Rules and Regulations 20227 

labor monitoring system they intend to 

market. 

II. What is The Environmental Impact 

Of This Rule? 

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. Thus, neither 

an environmental assessment nor an 

environmental impact statement is 

required. 

III. What is The Economic Impact Of 

This Rule? 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and 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 into class II will relieve 

manufacturers 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 economic 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 $122 

million, using the most current (2005) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1–year 

expenditure that would meet or exceed 

this amount. 

IV. Does This Final Rule Have 

Federalism Implications? 

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. How Does This Rule Comply with 

the Paperwork Reduction Act of 1995? 

This final rule contains no collections 

of information. Therefore, clearance by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 is not required. 

VI. What References are on Display? 

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 Barnev Ltd., dated October 

15, 2006. 

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 884.2800 is added to 

subpart C to read as follows: 

§ 884.2800 Computerized Labor 

Monitoring System. 

(a) Identification. A computerized 

labor monitoring system is a system 

intended to continuously measure 

cervical dilation and fetal head descent 

and provide a display that indicates the 

progress of labor. The computerized 

labor monitoring system includes a 

monitor and ultrasound transducers. 

Ultrasound transducers are placed on 

the maternal abdomen and cervix and 

on the fetal scalp to provide the matrix 

of measurements used to produce the 

display. 

(b) Classification. Class II (special 

controls). The special controls are the 

FDA guidance document entitled: 

‘‘Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Computerized Labor Monitoring 

Systems.’’ See § 884.1(e) for availability 

of this guidance document. 

Dated: April 13, 2007. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. E7–7702 Filed 4–23–07; 8:45 am] 

BILLING CODE 4160–01–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 63 

[EPA–HQ–OAR–2002–0093; FRL–8304–2] 

RIN 2060–AN10 

National Emission Standards for 

Hazardous Air Pollutants: Surface 

Coating of Automobiles and Light-Duty 

Trucks; National Emission Standards 

for Hazardous Air Pollutants for 

Surface Coating of Plastic Parts and 

Products 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is taking direct final 

action on amendments to the National 

Emission Standards for Hazardous Air 

Pollutants: Surface Coating of 

Automobiles and Light-Duty Trucks 

(Automobiles and Light-Duty Trucks 

NESHAP) which were promulgated on 

April 26, 2004, under the authority of 

section 112(d) of the Clean Air Act. The 

direct final rule amends provisions in 

the Automobiles and Light-Duty Trucks 

NESHAP to clarify the interaction 

between the Automobiles and LightDuty Trucks NESHAP and the National 

Emission Standards for Hazardous Air 

Pollutants for Surface Coating of Plastic 

Parts and Products (Plastic Parts 

NESHAP), to clarify the meaning of 

certain regulatory provisions, and to 

correct certain errors identified in the 

regulatory text. EPA is also taking direct 

final action on amendments to the 

Plastic Parts NESHAP to clarify that 

screen printing is not subject to that 

rule. 

DATES: The direct final rule is effective 

on June 25, 2007 without further notice, 


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