[Federal Register Volume 65, Number 61 (Wednesday, March 29, 2000)]
[Rules and Regulations]
[Pages 16520-16521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7541]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. 00P-0931]


Clinical Chemistry Devices; Classification of the Biotinidase 
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 
biotinidase test system into class II (special controls). The special 
control that will apply to this device is restriction to sale, 
distribution, and use as a prescription device. 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 
devices.

DATES: This rule is effective April 28, 2000.

FOR FURTHER INFORMATION CONTACT: Carol C. Benson, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-1243.

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 class 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 the FDA 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 19, 1999, classifying the Wallac Neonatal Biotinidase 
Test Kit 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 which was subsequently reclassified into class I or class II. 
On December 20, 1999, FDA filed a petition submitted by PerkinElmer 
requesting classification of the Wallac Neonatal Biotinidase Test Kit 
into class II under section 513(f)(2) of the act.
    After review of the information submitted in the petition, FDA 
determined that the Wallac Neonatal Biotinidase Test Kit can be 
classified in class II with the establishment of special controls. This 
device is intended for use in the semiquantitative in vitro 
determination of biotinidase activity in blood specimens collected onto 
filter paper to screen newborns for biotinidase deficiency, an inborn 
error of metabolism. 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, Wallac Neonatal 
Biotinidase Test Kit is subject to the following special control: The 
sale, distribution, and use of this device are restricted to 
prescription use in accordance with Sec. 801.109 (21 CFR 801.109). 
Section 510(m) of the act provides that FDA may exempt a class II 
device from the premarket notification requirements 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 the device and, therefore, the device is not 
exempt from the premarket notification requirements. The test is widely 
used in newborn screening programs and 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 biotinidase test system before marketing 
the device.

[[Page 16521]]

    On February 15, 2000, FDA issued an order to the petitioner 
classifying the Wallac Neonatal Biotinidase Test Kit, and substantially 
equivalent devices of this generic type, into class II under the 
generic name, biotinidase test system. FDA identifies this generic type 
of device as a biotinidase test system, which is intended to measure 
the activity of the enzyme biotinidase deficiency, an inborn error of 
metabolism in infants, characterized by the inability to utilize 
dietary protein bound vitamin, or to recycle endogenous biotin, and may 
result in irreversible neurological impairment. This order also 
identifies the following special control applicable to this device: 
Sale, distribution, and use of this device are restricted in accordance 
with the prescription device requirements in Sec. 801.109.

II. 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.

III. Analysis 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 104-121), 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 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. The agency knows of only one manufacturer of this 
device. Without this rule, the manufacturer would be required to obtain 
approval of a premarket approval application from FDA before marketing 
this device. Therefore, this rule reduces an economic burden for this 
manufacturer and any future manufacturers of this type of device. The 
agency, therefore, certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities. 
In addition, this final rule 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 is 
not required.

IV. 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.
    Therefore, under the Federal Food, Drug, and Cosmetic Act under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
862 is amended as follows:

List of Subjects in 21 CFR Part 862

    Medical devices.

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 862.1118 is added to subpart B to read as follows:


Sec. 862.1118  Biotinidase test system.

    (a) Identification. The biotinidase test system is an in vitro 
diagnostic device intended to measure the activity of the enzyme 
biotinidase in blood. Measurements of biotinidase are used in the 
treatment and diagnosis of biotinidase deficiency, an inborn error of 
metabolism in infants, characterized by the inability to utilize 
dietary protein bound vitamin or to recycle endogenous biotin. The 
deficiency may result in irreversible neurological impairment.
    (b) Classification. Class II (special controls). The special 
control is sale, distribution, and use in accordance with the 
prescription device requirements in Sec. 801.109 of this chapter.

    Dated: March 13, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-7541 Filed 3-28-00; 8:45 am]
BILLING CODE 4160-01-F