[Federal Register: November 24, 2004 (Volume 69, Number 226)]
[Rules and Regulations]
[Page 68254-68255]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24no04-6]
[[Page 68254]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 862
[Docket No. 2004N-0482]
Medical Devices; Clinical Chemistry and Clinical Toxicology
Devices; Classification of Newborn Screening Test Systems for Amino
Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass
Spectrometry
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying newborn
screening test systems for amino acids, free carnitine, and
acylcarnitines using tandem mass spectrometry into class II (special
controls). The special control that will apply to the device is the
guidance document entitled ``Class II Special Controls Guidance
Document: Newborn Screening Test Systems for Amino Acids, Free
Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry.'' 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, the Food and Drug Administration Modernization Act of 1997, and
the Medical Device User Fee and Modernization Act of 2002. The agency
is classifying the device into class II (special controls) in order to
provide a reasonable assurance of safety and effectiveness of the
device. Elsewhere in this issue of the Federal Register, FDA is
publishing a notice of availability of a guidance document that is the
special control for this device.
DATES: This rule becomes effective December 27, 2004. The
classification was effective August 24, 2004.
FOR FURTHER INFORMATION CONTACT: Carol Benson, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-1243, ext. 144.
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 part 807 (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 (section 513(f)(2) of the act).
In accordance with section 513(f)(1) of the act, FDA issued a
notice on June 9, 2004, classifying the Perkin Elmer Life and
Analytical Sciences' NeoGram Amino Acids and Acylcarnitines Tandem Mass
Spectrometry 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 July 2, 2004, Perkin Elmer Life and
Analytical Sciences submitted a petition requesting classification of
the NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit
under section 513(f)(2) of the act. The manufacturer recommended that
the device be classified into class II.
In accordance with section 513(f)(2) of the act, FDA reviewed the
petition in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the act. Devices are
to be classified into class II if general controls, by themselves, are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the petition, FDA determined that the Perkin
Elmer Life and Analytical Sciences' NeoGram Amino Acids and
Acylcarnitines Tandem Mass Spectrometry Kit can be classified in class
II with the establishment of special controls. FDA believes these
special controls, in addition to general controls, will provide
reasonable assurance of safety and effectiveness of the device.
The device is assigned the generic name ``newborn screening test
system for amino acids, free carnitine, and acylcarnitines using tandem
mass spectrometry.'' It is identified as a device intended for the
measurement and evaluation of amino acids, free carnitine, and
acylcarnitine concentrations from newborn whole blood filter paper
samples. The quantitative analysis of amino acids, free carnitine, and
acylcarnitines and their relationship with each other provides analyte
concentration profiles that may aid in screening newborns for one or
more inborn errors of amino acid, free carnitine, and acyl-carnitine
metabolism.
FDA has identified no direct risks to health related to use of
newborn screening test systems for amino acids, free carnitine, and
acylcarnitines using tandem mass spectrometry. However, failure of the
test to perform as indicated or error in interpretation of results may
lead to the indirect risk of improper medical management of patients
with inborn errors of metabolism. For example, a false negative (false
normal) measurement could contribute to failure to detect a possible
inborn error of metabolism, which could lead to functional impairment
or death. A false positive (false abnormal) measurement could
contribute to unnecessary additional patient testing and added concern
and apprehension of parents and physicians.
The class II special controls guidance document provides
information on how to meet premarket (510(k)) submission requirements
for the device, including recommendations on validation of performance
characteristics and labeling. FDA believes that following the class II
special controls guidance document generally addresses the risk to
health identified in the previous paragraph. Therefore, on August 24,
2004, FDA issued an order to the petitioner classifying the device into
class II. FDA is codifying this classification by adding 21 CFR
862.3840.
[[Page 68255]]
Following the effective date of this final classification rule, any
firm submitting a 510(k) premarket notification for a newborn screening
test system for amino acids, free carnitine, and acylcarnitines using
tandem mass spectrometry will need to address the issues covered in the
special controls guidance. However, the firm need only show that its
device meets the recommendations of the guidance or in some other way
provides equivalent assurance of safety and effectiveness.
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. For this type of device, however, FDA has
determined that premarket notification is necessary because FDA review
of performance characteristics, test methodology, and labeling to
satisfy requirements of Sec. 807.87(e), will provide reasonable
assurance that acceptable levels of performance for both safety and
effectiveness will be addressed before marketing clearance. Thus,
persons who intend to market this type of device must submit to FDA a
premarket notification containing information on the newborn test
system before marketing the device.
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 of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), 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 not a significant regulatory action 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. Because classification of these devices into class
II will relieve manufacturers 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
marketplace by lowering their costs, the agency certifies that the
final rule will not have a significant 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, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $110 million. FDA does not expect this final rule to
result in any 1-year expenditure that would meet or exceed this amount.
IV. 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 Executive order and, consequently, a
federalism summary impact statement is not required.
V. Paperwork Reduction Act of 1995
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VI. Reference
The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Petition from Perkin Elmer Life and Analytical Sciences,
dated July 2, 2004.
List of Subjects in 21 CFR Part 862
Medical devices.
0
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
0
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.
0
2. Section 862.1055 is added to subpart B to read as follows:
Sec. 862.1055 Newborn screening test system for amino acids, free
carnitine, and acylcarnitines using tandem mass spectrometry.
(a) Identification. A newborn screening test system for amino
acids, free carnitine, and acylcarnitines using tandem mass
spectrometry is a device that consists of stable isotope internal
standards, control materials, extraction solutions, flow solvents,
instrumentation, software packages, and other reagents and materials.
The device is intended for the measurement and evaluation of amino
acids, free carnitine, and acylcarnitine concentrations from newborn
whole blood filter paper samples. The quantitative analysis of amino
acids, free carnitine, and acylcarnitines and their relationship with
each other provides analyte concentration profiles that may aid in
screening newborns for one or more inborn errors of amino acid, free
carnitine, and acyl-carnitine metabolism.
(b) Classification. Class II (special controls). The special
control is FDA's guidance document entitled ``Class II Special Controls
Guidance Document: Newborn Screening Test Systems for Amino Acids, Free
Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry.'' See
Sec. 862.1(d) for the availability of this guidance document.
Dated: November 15, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-25975 Filed 11-23-04; 8:45 am]
BILLING CODE 4160-01-S