[Federal Register Volume 65, Number 129 (Wednesday, July 5, 2000)]
[Rules and Regulations]
[Pages 41330-41332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16808]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. 95N-0084]


Medical Devices; Effective Date of Requirement for Premarket 
Approval for a Class III Preamendments Obstetrical and Gynecological 
Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
to require the filing of a premarket approval application (PMA) or a 
notice of completion of product development protocol (PDP) for a Group 
1 preamendments class III device, the obstetric data analyzer intended 
to analyze data from fetal and maternal monitors during labor and to 
warn of possible fetal distress. The agency has summarized its findings 
regarding the degree of risk of illness or injury designed to be 
eliminated or reduced by requiring the device to meet the statute's 
approval requirements and the benefits to the public from the use of 
the devices.

DATES: This rule is effective July 5, 2000.

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

    In the Federal Register of May 6, 1994 (59 FR 23731), FDA issued a 
notice of availability of a preamendments class III devices strategy 
document. The strategy document set forth FDA's plans for implementing 
the provisions of section 515(i) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360e(i)) for preamendments class III 
devices for which FDA had not yet required premarket approval. FDA 
divided this universe of devices into three groups as referenced in the 
May 6, 1994, notice.
    In the Federal Register of September 7, 1995 (60 FR 46718), FDA 
published a proposed rule to require the filing under section 515(b) of 
the act of a PMA or a notice of completion of a PDP for 43 preamendment 
class III devices, including the obstetric data analyzer. In accordance 
with section 515(b)(A)(2) of the act, FDA included in the preamble to 
the proposal the agency's tentative findings with respect to the degree 
of risk of illness or injury designed to be eliminated or reduced by 
requiring the device to meet the premarket approval requirements of the 
act, and the benefits to the public from use of the device. The 
September 7, 1995, proposed rule also provided an opportunity for 
interested persons to submit comments on the proposed rule and the 
agency's findings. Under section 515(b)(2)(B) of the act, FDA provided 
an opportunity for interested persons to request a change in the 
classification of the device based on new information relevant to its 
classification. Any petition requesting a change in the classification 
of the devices was required to be submitted by September 22, 1995. The 
comment period closed January 5, 1996.
    FDA received one citizen petition requesting a change in the 
classification of the obstetrical data analyzer. FDA reviewed the 
petition, identified a deficiency in the petition, and issued a 
deficiency letter on March 7, 1996, to the petitioner. From the 
petitioner's response to the deficiency letter, it was apparent that 
the petitioner had misinterpreted the September 7, 1995, proposed rule 
because he believed that it was about another device and not the 
obstetrical data analyzer. In light of this petition, FDA has amended 
the identification of the device in Sec. 884.2050(a) by changing the 
first two sentences to read as follows: ``An obstetric data analyzer 
(fetal status data analyzer) is a device used during labor to analyze 
electronic signal data obtained from fetal and maternal monitors. The 
obstetric data analyzer provides clinical diagnosis of fetal

[[Page 41331]]

status and recommendations for labor management and clinical 
interventions.'' With this clarifying change, FDA is proceeding to 
issue a final rule to require the filing of a PMA or a PDP for the 
obstetric data analyzer.

II. Findings With Respect to Risks and Benefits

    Under section 515(b)(3) of the act, FDA is adopting the findings as 
published in the proposed rule of September 7, 1995. As required by 
section by section 515(b) of the act, FDA published its findings 
regarding: (1) The degree of risk of illness or injury designed to be 
eliminated or reduced by requiring that these devices have an approved 
PMA or a declared completed PDP; and (2) the benefits to the public 
from the use of the device.
    These findings are based on the reports and recommendations of the 
Obstetrical and Gynecological Devices Panel, an FDA advisory committee 
for the classification of the devices, along with any additional 
information FDA discovered. Additional information can be found in the 
proposed and final rules classifying the devices in the Federal 
Register of April 3, 1979 (44 FR 19894) and February 26, 1980 (45 FR 
12682), respectively.

III. The Final Rule

    Under section 515(b)(3) of the act, FDA is adopting the findings as 
published in the preamble to the proposed rule and issuing this final 
rule to require premarket approval of the generic type of device, the 
obstetric data analyzer, by revising 21 CFR part 884.
    Under the final rule, a PMA or a notice of completion of a PDP is 
required to be filed on or before October 3, 2000, for any obstetric 
data analyzer that was in commercial distribution before May 28, 1976, 
or that has been found by FDA to be substantially equivalent to such a 
device on or before October 3, 2000. An approved PMA or a declared 
completed PDP is required to be in effect for any such devices on or 
before 180 days after FDA files the application. Any other obstetric 
data analyzer that was not in commercial distribution before May 28, 
1976, is required to have an approved PMA or a declared completed PDP 
in effect before it may be marketed.
    If a PMA or a notice of completion of a PDP for an obstetric data 
analyzer is not filed on or before the 90th day past the effective date 
of this regulation, that device will be deemed adulterated under 
section 501(f)(1)(A) of the act (21 U.S.C. 351(f)(1)(A)), and 
commercial distribution of the device will be required to cease 
immediately. The device may, however, be distributed for 
investigational use, if the requirements of the investigational device 
exemption (IDE) regulations (21 CFR part 812) are met.
    Under Sec. 812.2(d) of the IDE regulations, FDA hereby stipulates 
that the exemptions from the IDE requirements in Sec. 812.2(c)(1) and 
(c)(2) will no longer apply to clinical investigations of the obstetric 
data analyzer. Further, FDA concludes that investigational obstetric 
data analyzers are significant risk devices as defined in Sec. 812.3(m) 
and advises that, as of the effective date of Sec. 878.3530(c), the 
requirements of the IDE regulations regarding significant risk devices 
will apply to any clinical investigation of an obstetric data analyzer. 
For any obstetric data analyzer that is not subject to a timely filed 
PMA or PDP, an IDE must be in effect under Sec. 812.20 on or before 90 
days after the effective date of this regulation or distribution of the 
device must cease. FDA advises all persons presently sponsoring a 
clinical investigation involving the obstetric data analyzer to submit 
an IDE application to FDA no later than 60 days after the effective 
date of this final rule to avoid the interruption of ongoing 
investigations.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this 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.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Public Law 96-354), 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 economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The agency believes that this final rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
Order. In addition, the 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.
    If a rule has a significant economic impact on a substantial number 
of small entities, the Regulatory Flexibility Act requires agencies to 
analyze regulatory options that would minimize any significant impact 
of a rule on small entities. Because FDA believes that there is little 
or no interest in marketing these devices, the agency certifies that 
the final rule, if issued, will not have a significant impact on a 
substantial number of small entities. Therefore, under the Regulatory 
Flexibility Act, no further analysis is required.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public 
Law 104-4) requires that agencies prepare a written statement of 
anticipated costs and benefits before proposing any rule that may 
result in an expenditure by State, local, and tribal governments, in 
the aggregate, or by the private sector, of $100 million in any one 
year (adjusted annually for inflation). The Unfunded Mandates Reform 
Act does not require FDA to prepare a statement of costs and benefits 
for the final rule, because the proposed rule is not expected to result 
in any 1-year expenditure that would exceed $100 million adjusted for 
inflation.

VI. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no new collections of 
information. The premarket approval program information collection is 
approved by the Office of Management and Budget (OMB) under OMB Control 
No. 0910-0231. Therefore, clearance by under the Paperwork Reduction 
Act of 1995 is not required.

VII. 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

[[Page 41332]]

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 884.2050 is revised to read as follows:


Sec. 884.2050  Obstetric data analyzer.

    (a) Identification. An obstetric data analyzer (fetal status data 
analyzer) is a device used during labor to analyze electronic signal 
data obtained from fetal and maternal monitors. The obstetric data 
analyzer provides clinical diagnosis of fetal status and 
recommendations for labor management and clinical interventions. This 
generic type of device may include signal analysis and display 
equipment, electronic interfaces for other equipment, and power 
supplies and component parts.
    (b) Classification: Class III (premarket approval).
    (c) Date PMA or notice of completion of PDP is required. A PMA or a 
notice of completion of a PDP is required to be filed with the Food and 
Drug Administration on or before October 3, 2000, for any obstetric 
data analyzer described in paragraph (a) of this section that was in 
commercial distribution before May 28, 1976, or that has been found, on 
or before October 3, 2000, to be substantially equivalent to an 
obstetric data analyzer described in paragraph (a) of this section that 
was in commercial distribution before May 28, 1976. Any other obstetric 
data analyzer described in paragraph (a) of this section shall have an 
approved PMA or declared completed PDP in effect before being placed in 
commercial distribution.

    Dated: June 22, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-16808 Filed 7-5-00; 8:45 am]
BILLING CODE 4160-01-F