[Federal Register Volume 66, Number 40 (Wednesday, February 28, 2001)]
[Rules and Regulations]
[Pages 12733-12734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4847]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. 00P-1675]


Clinical Chemistry and Clinical Toxicology Devices; 
Classification of B-Type Natriuretic Peptide Test System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the B-
type natriuretic peptide (BNP) test system into class II (special 
controls). The special control that will apply to this device is a 
guidance document entitled ``Class II Special Control Guidance Document 
for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance 
for Industry and FDA Reviewers.'' The agency is taking this action in 
response to a petition submitted under the Federal Food, Drug, and 
Cosmetic Act (the act) as amended by the Medical Device Amendments of 
1976, the Safe Medical Devices Act of 1990, and the Food and Drug 
Administration Modernization Act of 1997. The agency is classifying 
these devices into class II (special controls) in order to provide a 
reasonable assurance of the safety and effectiveness of the device.

DATES: This rule is effective February 28, 2001.

FOR FURTHER INFORMATION CONTACT: Jean M. Cooper, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-1293.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of the act (21 U.S.C. 
360c(f)(1)), devices that were not in commercial distribution before 
May 28, 1976, the date of enactment of the Medical Device Amendments of 
1976 (the amendments), generally referred to as postamendments devices, 
are classified automatically by statute into class III without any FDA 
rulemaking process. These devices remain in class III and require 
premarket approval, unless and until the device is classified or 
reclassified into class I or II or FDA issues an order finding the 
device to be substantially equivalent, in accordance with section 
513(i) of the act, to a predicate device that does not require 
premarket approval. The agency determines whether new devices are 
substantially equivalent to previously marketed 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 FDA's regulations.
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act for a device 
that has not previously been classified may, within 30 days after 
receiving an order classifying the device in class III under section 
513(f)(1) of the act, request FDA to classify the device under the 
criteria set forth in section 513(a)(1) of the act. FDA shall, within 
60 days of receiving such a request, classify the device by written 
order. This classification shall be the initial classification of the 
device. Within 30 days after the issuance of an order classifying the 
device, FDA must publish a notice in the Federal Register announcing 
such classification.
    In accordance with section 513(f)(1) of the act, FDA issued an 
order on November 13, 2000, classifying the BNP test in class III, 
because it was not substantially equivalent to a device that was 
introduced or delivered for introduction into interstate commerce for 
commercial distribution before May 28, 1976, or a device that was 
subsequently reclassified into class I or II. On November 15, 2000, FDA 
received a petition submitted by Biosite Diagnostic, Inc., requesting 
classification of the BNP test system into class II under section 
513(f)(2) of the act.
    After review of the information submitted in the petition, FDA 
determined that the Biosite Diagnostics BNP test system can be 
classified in class II with the establishment of special controls. This 
device is intended to measure BNP in whole blood and plasma as an aid 
in the diagnosis of patients with congestive heart failure. FDA 
believes that class II special controls, in addition to the general 
controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    In addition to the general controls of the act, the Biosite 
Diagnostics BNP test system is subject to a special control guidance 
document entitled ``Class II Special Control Guidance Document for B-
Type Natriuretic Peptide Premarket Notifications; Final Guidance for 
Industry and FDA Reviewers.''
    Section 510(m) of the act provides that FDA may exempt a class II 
device from the premarket notification requirement under section 510(k) 
of the act, if FDA determines that premarket notification is not 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device. FDA has determined that premarket 
notification is necessary to provide reasonable assurance of the safety 
and effectiveness of this type of device and, therefore, the device is 
not exempt from the premarket notification requirements. The test is 
used in the diagnosis of patients with congestive heart failure. FDA 
review of data sets and labeling ensure that minimum levels of 
performance are obtained before marketing and are subject to impartial 
external quality control before labeling is put into place. Thus, 
persons who intend to market this device must submit to FDA a premarket 
notification submission containing information on the BNP test system 
before marketing the device.
    On November 20, 2000, FDA issued an order to the petitioner 
classifying the Biosite Diagnostics BNP test system, and substantially 
equivalent devices of this generic type, into class II under the 
generic name, BNP test system. FDA identifies this generic type of 
device as a BNP test system, which is intended to aid in the diagnosis 
of congestive heart failure. FDA is codifying this device by adding 
Sec. 862.1117. This order also identifies a special control applicable 
to this device ``Class II Special Control Guidance Document for B-Type 
Natriuretic Peptide Premarket Notifications; Final Guidance for 
Industry and FDA Reviewers.''

II. Electronic Access

    In order to receive the draft guidance entitled ``Class II Special 
Control Guidance Document for B-Type Natriuretic Peptide Premarket 
Notifications; Final Guidance for Industry and FDA Reviewers'' via your 
fax machine, call the CDRH Facts on Demand System at 800-899-0381 or 
301-827-0111 from a touch-tone

[[Page 12734]]

telephone. At the first voice prompt press 1 to enter the system. At 
the second voice prompt press 1 to order a document. Enter the document 
number (1183) followed by the pound sign (#). Follow the remaining 
voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so using the Internet. CDRH maintains an entry on the Internet 
for easy access to information including text, graphics, and files that 
may be downloaded to a personal computer with access to the Internet. 
The CDRH home page may be accessed at http://www.fda.gov/cdrh. ``Class 
II Special Control Guidance Document for B-Type Natriuretic Peptide 
Premarket Notification; Final Guidance for Industry and FDA Reviewers'' 
is available at http://www.fda.gov/cdrh/ode/guidance/1072.pdf.

III. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. 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 Fairness Act of 
1996 (Public Law 104-1210), 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 it 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. FDA knows of only one manufacturer of this type of 
device. Classification of these devices in class II will relieve this 
manufacturer of the device of the cost of complying with the premarket 
approval requirements of section 515 of the act (21 U.S.C. 360e) and 
may permit small potential competitors to enter the market place 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.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 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 final rule is not expected to result in any 1-year expenditure that 
would exceed $100 million.

V. 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.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 862

    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 
862 is amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

    1. The authority citation for 21 CFR part 862 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.


    2. Section 862.1117 is added to subpart B to read as follows:


Sec. 862.1117  B-type natriuretic peptide test system.

    (a) Identification. The B-type natriuretic peptide (BNP) test 
system is an in vitro diagnostic device intended to measure BNP in 
whole blood and plasma. Measurements of BNP are used as an aid in the 
diagnosis of patients with congestive heart failure.
    (b) Classification. Class II (special controls). The special 
control is ``Class II Special Control Guidance Document for B-Type 
Natriuretic Peptide Premarket Notifications; Final Guidance for 
Industry and FDA Reviewers.''

    Dated: January 11, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-4847 Filed 2-27-01; 8:45 am]
BILLING CODE 4160-01-F