[Federal Register Volume 64, Number 146 (Friday, July 30, 1999)]
[Notices]
[Pages 41435-41440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19530]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97P-0350]


Obstetrics and Gynecology Devices; Reclassification of Home 
Uterine Activity Monitor

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of panel recommendation.

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SUMMARY: The Food and Drug Administration (FDA) is announcing for 
public comment the recommendation of the Obstetrics and Gynecology 
Devices Panel (the Panel) to reclassify the home uterine activity 
monitor (HUAM) from class III to class II. The Panel made this 
recommendation after reviewing the reclassification petition submitted 
by Corometrics Medical Systems, Inc., and other publicly available 
information. FDA also is announcing for public comment its tentative 
findings on the Panel's recommendation. After considering any public 
comments on the Panel's recommendation and FDA's tentative findings, 
FDA will approve or deny the reclassification petition by order in the 
form of a letter to the petitioner. FDA's decision on the 
reclassification petition will be announced in the Federal Register. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
notice of availability of a guidance document that provides 510(k) 
applicants with specific directions regarding data and information that 
should be submitted to FDA in 510(k) submissions for HUAM's.

DATES: Written comments by October 28, 1999.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

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 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 (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 the device is 
reclassified into class I or II or 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

[[Page 41436]]

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 classified 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.
    Under section 513(f)(2)(B)(i) of the act, the Secretary may, for 
good cause shown, refer a petition to a device classification 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

A. Preamendments Devices

    Before enactment of the 1976 amendments, tokodynamometers, 
integrated into electronic perinatal monitoring systems, were in 
commercial distribution. A tokodynamometer is a transducer and 
monitoring system used to make continuous external (abdominal) 
measurements of intrauterine pressure and provide strip chart tracings 
of the uterine contractions of a pregnant woman during labor. 
Preamendments perinatal monitors were marketed as systems for use in 
clinical settings, with different models for the office or hospital, 
and intended for clinical evaluation of the fetus and mother. In 1980, 
FDA classified these preamendments monitors (external uterine 
contraction monitor (21 CFR 884.2720) and perinatal monitoring system 
(21 CFR 884.2740) into class II.

B. Premarket Notifications

    Between 1984 and 1987, FDA reviewed 510(k)'s for several HUAM's and 
found these HUAM's to be substantially equivalent to tokodynamometers 
used in clinical settings. HUAM manufacturers were permitted to market 
these devices for use in ``low risk at-term'' pregnancies. However, FDA 
determined that use of the HUAM for ``the early detection of preterm 
labor (PTL) in high risk patients'' constituted a new intended use. For 
this new use, FDA determined that the HUAM was not substantially 
equivalent to any preamendments class I, class II, or class III device 
not subject to an approved PMA, or to any postamendments device that 
had been classified into class I or class II for the early detection of 
PTL. Accordingly, FDA advised HUAM manufacturers that the device was 
classified into class III under section 513(f)(1) of the act, and that 
it could not be placed in commercial distribution for early detection 
of PTL in high risk patients unless it was reclassified under section 
513(f)(2), or subject to an approved PMA under section 515 of the act.

C. PMA Reviews and Related Issues

    Subsequent to 1987, several PMA's for HUAM's were submitted to FDA 
and referred to the Panel for its recommendations.
    On May 26, 1988, the first PMA the Panel considered was the Tokos' 
Term GuardTM device. The Panel recommended that this PMA not 
be approved because the supporting data did not show the individual 
contribution the monitor made to the early detection of PTL, over and 
above that attributable to the regimen of daily patient contact (Ref. 
1).
    On March 6, 1989, the Panel reviewed a PMA submitted by Healthdyne, 
Inc., for its System 37TM HUAM and recommended that the PMA 
be found not approvable because the primary study endpoint (physician 
intervention) was considered too subjective and the study lacked a 
control group (Ref. 2).
    On January 18 and April 4, 1990, the Panel reviewed a PMA submitted 
by Physiological Diagnostic Systems, Inc., for its GenesisTM 
HUAM. This PMA was supported by a randomized controlled clinical study 
that demonstrated the individual contribution of the monitor to the 
early detection of PTL, as evidenced by cervical dilation at the time 
of PTL diagnosis. These data, within the study, were compared with the 
standard care for high risk patients without monitoring. On the basis 
of this data, the Panel recommended approval of the 
GenesisTM HUAM for the early detection of PTL in only one 
high risk patient group (Refs. 3 and 4). Subsequently, on September 12, 
1990, FDA approved a PMA for the GenesisTM HUAM. This HUAM 
is indicated for use, in conjunction with standard high risk care, for 
the daily at-home measurement of uterine activity in pregnancies 
24 weeks gestation for women with a history of previous 
preterm birth. With the GenesisTM system, uterine activity 
is displayed at a remote location to aid in the early detection of PTL, 
as evidenced by cervical dilation at the time of PTL diagnosis (Ref. 
5).
    On June 11, 1990, the Panel reviewed a new PMA from Healthdyne for 
its System 37TM HUAM. Healthdyne submitted new data and 
claimed that the System 37TM would identify women, already 
known to be a high risk for PTL, who were at an even higher risk of 
preterm birth. The Panel recommended that this PMA not be approved 
because of inherent study design flaws. In particular, the outcome 
variable (incidence of preterm birth) had significant intra and 
interobserver variation, and the study entry criteria were biased (Ref. 
6).
    On April 29 and 30, 1993, the Panel reviewed a PMA for the DT 100-P 
HUAM manufactured by Advanced Medical Systems. This HUAM system was 
indicated for the early detection of PTL in women with twin gestations. 
The Panel reviewed the PMA and recommended that the PMA be found not 
approvable because all the key clinical data came from only one site 
and because significant engineering questions regarding the monitoring 
system were unanswered.
    The Panel also considered several FDA prepared questions on the 
interpretation of clinical study findings supporting other PMA's under 
review. In addition, the Panel addressed certain issues relative to the 
existing draft guidance document entitled ``Premarket Testing 
Guidelines for Home Uterine Activity Monitors'' (March 31, 1993). 
Issues discussed included: (1) The use of a random sample of examiners 
to address intra and interobserver variance; (2) the use of a standard 
definition for the terms ``preterm labor'' and ``standard of care for 
high risk patients''; (3) limiting study inclusions

[[Page 41437]]

to a minimum gestational age of 20 weeks; and (4) allowing the use of 
subgroup analysis, except for the purpose of making promotional claims. 
The Panel also noted the importance of blinding procedures for patients 
and investigators, but did not go so far as to identify it as a 
requirement.
    During the April 1993 meeting, the Panel stressed that FDA should 
look at how the HUAM device is promoted and how often it is used for 
indications for which it is not approved in the context of postapproval 
studies or annual reporting (Ref. 7). Also, during this meeting, FDA 
informed the industry that in light of the many published studies on 
HUAM's, the devices were a good candidate for reclassification and 
invited them to petition FDA for a change in classification of the 
devices.
    During the Panel meeting of September 2, 1994, FDA sought 
additional guidance regarding clinical review issues on HUAM PMA's. The 
Panel reconsidered whether cervical dilation at the time of PTL 
diagnosis should remain the primary clinical endpoint. Alternative 
endpoints were discussed and despite the difficulties and imperfections 
of using cervical dilation, the Panel concluded that this endpoint 
should remain an acceptable alternative for HUAM efficacy studies (Ref. 
8).
    During the Panel meeting of April 24, 1995 (Ref. 9), Caremark, 
Inc., presented the clinical efficacy study results for its First 
Activity HUAM. The study included design elements 
specifically recommended and preferred by the Panel, including a sham 
control. When compared to standard clinical care for high risk 
patients, the study showed no added benefit when using an HUAM for 
either early PTL detection or reduced preterm births. These findings 
did not persuade the Panel to change its earlier recommendations 
regarding acceptable elements of study designs.
    On September 29, 1995, FDA approved PMA's for Healthdyne's System 
37TM and CareLink Corp.'s CareFoneTM HUAM's, for 
the same indication as the GenesisTM HUAM; i.e., in 
conjunction with standard high risk care, the HUAM was approved for the 
daily at-home measurement of uterine activity in pregnancies, 
24 weeks gestation, for women with a history of previous 
preterm birth. The uterine activity of these devices is also displayed 
at a remote location to aid in the early detection of PTL.

D. Reclassification Petition

    On August 15, 1997, FDA received a petition from Corometrics 
Medical Systems, Inc., for its Model 770 BMS HUAM system requesting FDA 
to reclassify the HUAM system from class III to class II under section 
513(f)(2) of the act and Sec. 860.134, based on information submitted 
in the petition (Ref. 10).
    Consistent with the act and the regulation, FDA referred the 
petition to the Panel for its recommendation on the requested change in 
classification.

III. Device Description

    A home uterine activity monitor is an at-home monitoring system 
that consists of a tocotransducer and abdominal belt, an at-home 
recorder/memory system, a telephone data transmitter (at-home modem), 
and a separate data receiving, storage, and display system that is 
located, remote from the home, in a clinical setting (data receiving 
center). The device is intended to be used on women with a previous 
preterm delivery to aid in the detection of PTL.
    At home, per instructions by the obstetrician, a pregnant woman 
secures the tocotransducer around her abdomen for a specified duration 
and frequency. Uterine muscular distention (tone) changes, indirectly 
detected by the tocotransducer, are recorded and stored in the 
recorder/memory. Either immediately after recording or at a later time, 
the uterine activity data is transmitted via the modem to the data 
receiving center for clinical evaluation.
    The receiving center has a computerized system with specialized 
software to receive, store, and display the uterine activity data for 
clinical evaluation at the remote clinical site. Based on the 
evaluation of the uterine activity tracing, the patient is referred to 
her obstetrician for further followup to determine whether she has 
started PTL.

IV. Recommendations of the Panel

    In a public meeting on October 7, 1997, the Panel unanimously 
recommended that the HUAM be reclassified from class III to class II 
for use in early detection of PTL, as evidenced by cervical dilation at 
PTL diagnosis, for women with a previous history of preterm birth 
(Refs. 11 and 12). The Panel believed that class II with special 
controls of patient registries, bench testing, consensus standards, and 
clinical validation studies would provide reasonable assurance of the 
safety and effectiveness the device.

V. Risks to Health

    During its review and discussion of the proposed reclassification 
of the HUAM, the Panel identified certain risks to health they believed 
were associated with use of the HUAM. The risks were identified as : 
(1) Off-label use; (2) initiation of a cascade of interventions 
including bed rest, hospitalization, and medications; and (3) 
disabilities and psychological concerns, such as quality of life 
issues. The Panel had other concerns they believed were hazards to 
health. They identified the specific hazards as needless exposure to 
tocolytics and steroids resulting from detection of clinically 
meaningless contractions, alterations in quality of life from false 
positives, and inability to identify contractions because of a failure 
of the transducer to be sensitive and specific.
    After considering the discussion by the Panel during the 
reclassification proceedings, reviewing the reclassification petition, 
medical device reports, and published literature, FDA identified the 
following risks it believed are associated with use of the HUAM when 
used in early detection of PTL, as evidenced by cervical dilation at 
PTL diagnosis, for women with a history of previous preterm birth:

A. Electric Shock and/or Injury

    HUAM's are electrically powered devices which can cause electrical 
shock to the patient or clinician, leading to injury or death. This 
potential risk is well understood, and it can be mitigated by 
appropriate system design such as sufficient electrical isolation and 
other safety measures in accordance with applicable consensus 
standards.

B. Skin Irritation and Sensitization

    HUAM's have accessories that make contact with the skin, namely, 
the tocotransducer and abdominal belt. Any material that comes in 
contact with the skin has the potential for causing skin irritation and 
sensitization. This risk can be lessened, if it occurs, by a consensus 
standard for material safety.

C. Unnecessary Evaluation and Treatment

    Unnecessary evaluation and treatment may result from an imprecise 
definition of PTL or failure of an HUAM to accurately depict uterine 
activity. Diagnosis of PTL is often difficult, and many times can only 
be confirmed retrospectively by the preterm delivery. Nonetheless, the 
consequences of preterm delivery can be devastating in terms of 
neonatal morbidity and mortality. There is a concern that the use of an 
HUAM system can cause unnecessary visits to the clinic which could, in 
turn, lead to over-diagnosis of PTL and unnecessary treatment with 
tocolytics for women who have increased uterine activity but are not 
destined for preterm delivery. Improper device design or a 
malfunctioning

[[Page 41438]]

device can also result in an apparent increase in uterine activity and 
unnecessary clinical visits, thereby leading to unnecessary treatment 
with tocolytic agents intended to stop or slow labor.

D. Disabilities and Psychological Issues

    Physical disabilities and psychological burdens may result from the 
clinical management of women diagnosed with PTL. For example, the use 
of some tocolytic agents sometimes causes temporary or permanent injury 
to the mother. Moreover, the HUAM regimen coupled with a tocolysis 
regimen can significantly disrupt a woman's pregnancy and her quality 
of life. Nonetheless, it is noted that a high risk pregnancy is often 
psychologically debilitating to the patient, and tocolytics may be 
prescribed for unmonitored women as well.

E. Other Risks From Use in Unproven Patient Populations

    HUAM's have only been approved for use on women who have had a 
previous preterm delivery. The overuse of HUAM's for other indications, 
i.e., PTL in the current pregnancy, multiple gestations, etc., were 
expressed concerns of the Panel. The clinical utility for these other 
indications has not been proven.

VI. Benefits

    HUAM's provide a benefit to high risk patients by helping to detect 
PTL at an early stage, as evidenced by cervical dilation, thereby 
allowing for early management of PTL. Early detection of PTL increases 
the likelihood of successful tocolysis, leading hopefully to the 
ultimate benefit of fewer preterm births and lower infant mortality and 
premature births. However, because this is only a monitoring device, 
FDA has required HUAM manufacturers to show that the devices provide 
contraction information that contributes to the diagnosis of PTL. 
Manufacturers are not required to show a reduction in the outcome 
measures because they are a result of successful intervention after 
diagnosis.
    HUAM technology is well-established with a long history of safe use 
at home and in the clinical setting. HUAM device design does not vary 
substantially from manufacturer to manufacturer in terms of underlying 
technology and clinical performance. Specific design choices are not 
expected to affect the risk to the patient. Therefore, FDA believes 
that randomized controlled clinical studies intended to show early PTL 
detection are no longer necessary and that the special controls 
described in section IX of this document would provide reasonable 
assurance of the safety and effectiveness of the device.

VII. Summary of Reasons for Recommendation

    After reviewing the data and information contained in the petition 
and provided by FDA, and after consideration of the open discussions 
during the Panel meetings and the Panel members' personal knowledge of 
and clinical experience with the device, the Panel gave the following 
reasons in support of its recommendation to reclassify the generic type 
HUAM for use, in conjunction with standard high risk care, in the daily 
at-home measurement of uterine activity in pregnancies 24 
weeks gestation for women with a history of previous preterm birth from 
class III into class II:
    1. The Panel believes that general controls by themselves are not 
sufficient to provide reasonable assurance of safety and effectiveness.
    2. The Panel believes that the HUAM should be reclassified into 
class II because special controls, in addition to general controls, 
provide reasonable assurance of the safety and effectiveness of the 
device, and there is sufficient information to establish special 
controls to provide such assurance.

VIII. Summary of Data Upon Which the Panel Recommendation is Based

    The Panel considered a large number of published clinical studies 
ranging in size, control, study population, and outcome measures (Ref. 
10). Statistical analyses of various studies were also considered. The 
Panel believed that these studies, as an aggregate, established the 
effectiveness of HUAM's, and qualified their effectiveness as an 
adjunctive tool for monitoring high risk pregnancies. At least one 
study showed that when HUAM's are used in combination with daily 
nursing care, PTL can be detected earlier than it is detected by the 
standard clinical management of patients at high risk for PTL (Ref. 
12). Other studies showed that when used without daily nursing contact, 
HUAM's detected PTL earlier (as evidenced by cervical dilation at the 
time of PTL diagnosis) than standard clinical care of a select patient 
populations (Refs. 5 and 14). On the other hand, some controlled 
studies showed that, for high risk populations, HUAM's do not 
contribute to PTL detection rate or a reduction in preterm deliveries 
when used with daily nursing contact (Refs. 15 and 16). Some studies 
evaluated HUAM's for managing pregnant women who were at risk for 
preterm birth for other reasons, e.g., multiple gestation and PTL in 
the current pregnancy (Refs. 5, 12, 13, 14, 15, and 16). The Panel did 
not evaluate the evidence for these indications.
    Most of the risks associated with HUAM's identified by the Panel 
were indirect effects attributable to incorrect monitoring information 
or misinterpretation of monitoring information leading to misdiagnosis. 
The concern that the use of the device would result in an increase in 
the number of hospital visits and use of tocolytics was not borne out 
in the published literature. The potential risk of misdiagnosis is one 
that is generally mitigated by proper training, adequate labeling, and 
limited use of the device by the clinician.
    Based on the available information, FDA believes that the special 
controls discussed in section IX of this document are capable of 
providing reasonable assurance of the safety and effectiveness of the 
HUAM with regard to the identified risks to health of this device.

IX. Special Controls

    In addition to general controls, FDA believes that the special 
controls (patient registries and guidance document) discussed in this 
section are adequate to control the risks to health described for this 
device. Elsewhere in this issue of the Federal Register, FDA is 
publishing a notice of availability of a guidance document entitled 
``Home Uterine Activity Monitors: Guidance for the Submission of 510k 
Premarket Notifications'' that provides 510(k) applicants with specific 
directions regarding data and information that should be submitted to 
FDA in 510(k) submissions for HUAM's.

A. Patient Registries

    The rationale for using patient registries is that it provides a 
means for characterizing the nature of the patient population for which 
the device is actually used and to track information about the labor 
and delivery of women for whom the device was prescribed. FDA believes 
that using patient registries, in a structured sampling format, will 
provide outcome data that will contribute to appropriate use of the 
device.

B. Guidance Document (Home Uterine Activity Monitors: Guidance for the 
Submission of Premarket Notifications)

    This document incorporates: (1) The consensus standards from 
professional organizations to provide uniformity, (2) bench testing and 
validation study information to validate the effectiveness and 
performance of the device, and (3)

[[Page 41439]]

labeling to describe the device's capabilities and discourage off-label 
use.
1. Bench Testing
    Bench testing can validate the ability of the HUAM to operate 
(independently or in combination with clinical validation studies) as 
intended, i.e., to collect, store, and transmit data. Bench testing can 
also address the risk of false positives and the resulting 
inappropriate management of the patient. Appropriately designed bench 
testing will ensure that uterine activity, and contractions in 
particular, are accurately measured and displayed by the device, 
thereby minimizing false positives associated with the device.
2. Consensus Standards
    The International Electrotechnical Commission (IEC) standards 601-1 
for medical electrical equipment and 601-1-2 for general safety 
identify the electrical safety and electromagnetic compatibility 
aspects for any type electrical device. Adherence to these standards 
can control the risks of electrical shock and/or injury to the patient 
and clinician. Copies of these standards may be obtained from IEC, AT3, 
Rue de Varembe, P.O. Box 131, Geneva, Switzerland, CH-1211. IEC also 
maintains a site on the world wide web at ``http://www.iec.ch''. 
Testing in accordance with any of a variety of material safety 
consensus standards, such as ISO-10993, Biological Evaluation of 
Medical Devices, Part 1: Evaluation and Testing, can minimize the risks 
of skin irritation and sensitization caused by the tocotransducer and 
abdominal belt. Copies of this and other material safety standards may 
be obtained from International Organization for Standardization, Case 
Postal, Geneva, Switzerland, CH-1121. ISO also maintains a site on the 
World Wide Web at ``http://www.iso.org''.
3. Clinical Validation Study
    The rationale for using a clinical validation study is to address 
the risk of false positives and the resulting inappropriate management 
of the patient. The objective of this limited clinical validation study 
is to address the remaining performance issues of the device, namely, 
the recording and data transmission functions that cannot be addressed 
via bench testing. The system should be tested in a small clinical 
study, in its intended setting with actual subjects. The study 
endpoints should address the readability of the received tracings, 
i.e., are the contractions correctly perceived by the clinician. The 
outcome of a limited clinical validation study would address and 
possibly mitigate the risk of unnecessary evaluation and treatment of 
the patient.
4. Labeling Requirements
    Labeling addresses the risk of use of the device in unproved 
patient populations. Diagnosis of PTL is often difficult, and many 
times can only be confirmed retrospectively by the actual preterm 
delivery. Yet, the consequences of preterm delivery can be devastating 
in terms of neonatal morbidity and mortality. An HUAM system that 
causes additional visits to a clinic could lead to over-diagnosis of 
PTL and unnecessary treatment with tocolytics for women who have 
increased uterine activity but are not destined for preterm delivery. 
Labeling should provide an accurate description of the device's 
capabilities and discourage the off-label use of the device and limit 
the perpetuation of false claims of the device's capabilities.
    FDA believes labeling which describes the capabilities and 
limitations of the HUAM system device can lead to a more informed use 
of this technology by the clinician, thereby mitigating the risks of 
unnecessary evaluations and treatments, disabilities, and psychological 
issues.

X. FDA's Tentative Findings

    The Panel and FDA believe that the HUAM should be classified into 
class II because special controls, in addition to general controls, 
would provide reasonable assurance of the safety and effectiveness of 
the device, and there is sufficient information to established special 
controls to provide such assurance.

XI. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday:
    1. Obstetrics and Gynecology Devices Panel Meeting, Summary 
Minutes, May 26, 1988.
    2. Obstetrics and Gynecology Devices Panel Meeting, Summary 
Minutes, March 6, 1989.
    3. Obstetrics and Gynecology Devices Panel Meeting, Summary 
Minutes, January 18, 1990.
    4. Obstetrics and Gynecology Devices Panel Meeting, Summary 
Minutes, April 4, 1990.
    5. Mou, S. M. et al., ``Multicenter Randomized Clinical Trial of 
Home Uterine Activity Monitoring for Detection of Preterm Labor,'' 
American Journal of Obstetrics and Gynecology, 165(4)1:858-866, 
1991.
    6. Obstetrics and Gynecology Devices Panel Meeting, Summary 
Minutes, June 11, 1990.
    7. Obstetrics and Gynecology Devices Panel Meeting, Summary 
Minutes, April 29 and 30, 1993.
    8. Obstetrics and Gynecology Devices Panel Meeting, Summary 
Minutes, September 2, 1994.
    9. Obstetrics and Gynecology Devices Panel Meeting, Summary 
Minutes, April 24, 1995.
    10. Reclassification Petition Submitted by Corometrics Medical 
Systems, Inc., June 5, 1997.
    11. Obstetrics and Gynecology Devices Panel Meeting, Transcript, 
October 7, 1997.
    12. Hill, W. C. et al., ``Home Uterine Activity Monitoring is 
Associated With a Reduction in Preterm Birth,'' Obstetrics and 
Gynecology, 76 (1 Supplement):13s-18s, 1990.
    13. Dyson, D. C. et al., ``Prevention of Preterm Birth in High 
Risk Patients: The Role of Education and Provider Contact versus 
Home Monitoring,'' American Journal of Obstertics and Gynecology, 
164(3):756-762, 1991.
    14. Wapner, R. J. et al., ``A Randomized Multicenter Trial 
Assessing a Home Uterine Activity Monitoring Device Used in the 
Absence of Daily Nursing Contact,'' American Journal of Obstetrics 
and Gynecology, 172(3):1026-1034, 1995.
    15. Blondel, B. et al., ``Home Uterine Activity Monitoring in 
France: A Randomized, Controlled Trial,'' American Journal of 
Obstetrics and Gynecology, 167(2):424-429, 1992.
    16. Iams, J. D., F. F. Johnson, and R. W. O-Shaughnessy, ``A 
Prospective Random Trial of Home Uterine Activity Monitoring in 
Pregnancies at Increased Risk of Preterm Labor, Part II,'' American 
Journal of Obstetrics and Gynecology, 150(3):595-603, 1988.

XII. Environmental Impact

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

XIII. Analysis of Impacts

    FDA has examined the impacts of the notice 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 Fairness 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

[[Page 41440]]

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, the reclassification action 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 manufacturers 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 reclassification action, if finalized, will not have a 
significant economic impact on a substantial number of small entities. 
In addition, this reclassification 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 
of analysis under section 202(a) of the Unfunded Mandates Reform Act of 
1995 is not required.

XIV. Request for Comments

    Interested persons may, on or before October 28, 1999, submit to 
the Dockets Management Branch (address above) written comments 
regarding this document. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m. Monday through Friday.

    Dated: June 30, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-19530 Filed 7-29-99; 8:45 am]
BILLING CODE 4160-01-F