[Federal Register Volume 72, Number 78 (Tuesday, April 24, 2007)]
[Rules and Regulations]
[Pages 20225-20227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-7702]


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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.

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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

[[Page 20226]]

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
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          Identified Risk                    Mitigation Measures
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Patient Injury                       Nonclinical Analysis and Testing
                                     Software
                                     Clinical Information
                                     Labeling
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Electrical Hazards                   Nonclinical Analysis and Testing
                                     Electrical Safety
                                     Labeling
------------------------------------------------------------------------
Acoustical (ultrasound) Tissue       Nonclinical Analysis and Testing
 Damage
                                     Ultrasound Safety
                                     Labeling
------------------------------------------------------------------------
Electromagnetic Interference and     Electromagnetic Compatibility
 Electrostatic Discharge Hazards
                                     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

[[Page 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.

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 884.2800 is added to subpart C to read as follows:


Sec.  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 Sec.  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