[Federal Register Volume 66, Number 47 (Friday, March 9, 2001)]
[Rules and Regulations]
[Pages 14074-14076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5813]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. 97P-0350]


Medical Devices; Reclassification and Codification of Home 
Uterine Activity Monitor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
has issued an order in the form of a letter to GE Marquette Medical 
Systems, Inc., reclassifying from class III to class II (special 
controls) the Corometrics Model 770 Home Uterine Activity Monitoring 
System for use in women with a previous preterm delivery to aid in the 
detection of preterm labor. Accordingly, the order is being codified in 
the Code of Federal Regulations. Elsewhere in this issue of the Federal 
Register, FDA is announcing the availability of a guidance document 
that will serve as the special control for this device.

DATES: This rule is effective April 9, 2001. The reclassification was 
effective January 5, 2001.

FOR FURTHER INFORMATION CONTACT: Colin M. Pollard, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1180.

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory Authorities)

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976

[[Page 14075]]

amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 
(the SMDA) (Public Law 101-629), and the Food and Drug Administration 
Modernization Act of 1997 (the FDAMA) (Public Law 105-115), established 
a comprehensive system for the regulation of medical devices intended 
for human use. Section 513 of the act (21 U.S.C. 360c) established 
three categories (classes) of devices, depending on the regulatory 
controls needed to provide reasonable assurance of their safety and 
effectiveness. The three categories of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval).
    Under section 513 of the act, devices that were in commercial 
distribution before May 28, 1976 (the date of enactment of the 1976 
amendments), generally referred to as preamendments devices, are 
classified after FDA has: (1) Received a recommendation from a device 
classification panel (an FDA advisory committee); (2) published the 
panel's recommendation for comment, along with a proposed regulation 
classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution prior to May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f) of the act) into class III 
without any FDA rulemaking process. Those devices remain in class III 
and require premarket approval, unless and until: (1) The device is 
reclassified into class I or II; (2) FDA issues an order classifying 
the device into class I or II in accordance with new section 513(f)(2) 
of the act, as amended by the FDAMA; or (3) FDA issues an order finding 
the device to be substantially equivalent, under 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 offered devices by means of premarket notification 
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR 
part 807 of the regulations.
    A preamendments device that has been classified into class III may 
be marketed, by means of premarket notification procedures, without 
submission of a premarket approval application (PMA) until FDA issues a 
final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) 
requiring premarket approval.
    Reclassification of postamendments devices is governed by section 
513(f)(2) of the act. This section provides that FDA may initiate the 
reclassification of a device classified into class III under section 
513(f)(1) of the act, or the manufacturer or importer of a device may 
petition the Secretary of Health and Human Services (the Secretary) for 
the issuance of an order classifying the device in class I or class II. 
FDA's regulations in Sec. 860.134 (21 CFR 860.134) set forth the 
procedures for the filing and review of a petition for reclassification 
of such class III devices. In order to change the classification of the 
device, it is necessary that the proposed new class have sufficient 
regulatory controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use.
    The FDAMA added a new section 513(f)(2) to the act that addresses 
classification of postamendments devices. New section 513(f)(2) of the 
act provides that, upon receipt of a ``not substantially equivalent'' 
determination, a 510(k) applicant may request FDA to classify a 
postamendments device into class I or class II. Within 60 days from the 
date of such a written request, FDA must classify the device by written 
order. If FDA classifies the device into class I or II, the applicant 
has then received clearance to market the device and it can be used as 
a predicate device for other 510(k)'s. It is expected that this process 
will be used for low risk devices. This process does not apply to 
devices that have been classified by regulation into class III, i.e., 
preamendments class III devices, or class III devices for which a PMA 
is appropriate.
    Under section 513(f)(3)(B)(i) of the act, formerly section 
513(f)(2)(B)(i) of the act, the Secretary may, for good cause shown, 
refer a petition to a device classification panel. If a petition is 
referred to a panel, the panel shall make a recommendation to the 
Secretary respecting approval or denial of the petition. Any such 
recommendation shall contain: (1) A summary of the reasons for the 
recommendation, (2) a summary of the data upon which the recommendation 
is based, and (3) an identification of the risks to health (if any) 
presented by the device with respect to which the petition was filed.

II. Regulatory History of the Device

    On August 15, 1997, FDA filed the reclassification petition 
submitted by GE Marquette Medical Systems, Inc., requesting 
reclassification of the Corometrics Model 770 Home Uterine Activity 
Monitoring System from class III to class II. FDA consulted with the 
Obstetrics and Gynecology Devices Panel (the Panel). During an open 
public meeting on October 7, 1997, the Panel recommended that FDA 
reclassify from class III to class II the Model 770 Home Uterine 
Activity Monitoring System for use in women with a previous preterm 
delivery to aid in the detection of preterm labor. The Panel also 
recommended patient registries, bench testing, consensus standards, and 
clinical validation studies as special controls.
    FDA considered the Panel's recommendations and tentatively agreed 
that the generic type of device, home uterine activity monitor, for use 
in women with a previous preterm delivery to aid in the detection of 
preterm labor, be reclassified from class III to class II. 
Subsequently, in the Federal Register of July 30, 1999 (64 FR 41435), 
FDA issued the Panel's recommendation for public comment.
    After reviewing the data in the petition and presented before the 
Panel, and after considering the Panel's recommendation and the 
comments, FDA, based on the information set forth, issued an order to 
the petitioner on January 5, 2001, reclassifying the Model 770 Home 
Uterine Activity Monitoring System, and substantially equivalent 
devices of this generic type, from class III to class II.
    Accordingly, as required by Sec. 860.134(b)(6) and (b)(7) of the 
regulations, FDA is announcing the reclassification of the generic Home 
Uterine Activity Monitor from class III into class II. The special 
control for this device will be a guidance document entitled ``Class II 
Special Controls Guidance Document for Home Uterine Activity 
Monitors.'' The guidance document addresses labeling, patient 
registries, design controls, consensus standards, and pre-clinical and 
clinical testing. In addition, FDA is issuing the notice to codify the 
reclassification of the device by adding new Sec.  884.2760.

III. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this 
reclassification 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.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory

[[Page 14076]]

Fairness Enforcement Act of 1996 (Public Law 104-121), 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 
reclassification action is consistent with the regulatory philosophy 
and principles identified in the Executive order. In addition, this 
final rule is not a significant regulatory action as defined by the 
Executive order and so is not subject to review 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. Reclassification of the device from class III to 
class II will relieve all manufacturers of the device of the cost of 
complying with the premarket approval requirements in section 515 of 
the act. Because reclassification will reduce regulatory costs with 
respect to this device, it will impose no significant economic impact 
on any small entities, and it may permit small potential competitors to 
enter the marketplace by lowering their costs. The agency therefore 
certifies that this final rule will not have a significant economic 
impact on a substantial number of small entities. In addition, this 
final rule action will not impose costs of $100 million or more on 
either the private sector or State, local, and tribal governments in 
the aggregate, and therefore a summary statement or analysis pursuant 
to section 202(a) of the Unfunded Mandates Reform Act of 1995 is not 
required.

V. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no information that is 
subject to review by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995. The special controls do not require 
the respondent to submit additional information to the public.

VI. 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 order and, consequently, a federalism 
summary impact statement is not required.

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 884.2730 is added to subpart C to read as follows:


Sec. 884.2730  Home uterine activity monitor.

    (a) Identification. A home uterine activity monitor (HUAM) is an 
electronic system for at home antepartum measurement of uterine 
contractions, data transmission by telephone to a clinical setting, and 
for receipt and display of the uterine contraction data at the clinic. 
The HUAM system comprises a tocotransducer, an at-home recorder, a 
modem, and a computer and monitor that receive, process, and display 
data. This device is intended for use in women with a previous preterm 
delivery to aid in the detection of preterm labor.
    (b) Classification. Class II (special controls); guidance document 
(Class II Special Controls Guidance for Home Uterine Activity 
Monitors).

    Dated: January 31, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-5813 Filed 3-8-01; 8:45 am]
BILLING CODE 4160-01-S