[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
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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
