
[Federal Register Volume 77, Number 57 (Friday, March 23, 2012)]
[Rules and Regulations]
[Pages 16925-16927]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6975]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2012-M-0206]


Medical Devices; Neurological Devices; Classification of the Near 
Infrared Brain Hematoma Detector

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the Near 
Infrared (NIR) Brain Hematoma Detector into class II (special 
controls). 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.

DATES: This rule is effective April 23, 2012. The classification is 
applicable beginning December 13, 2011.

FOR FURTHER INFORMATION CONTACT: Daryl Kaufman, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2426, Silver Spring, MD 20993-0002, 301-796-6467.

SUPPLEMENTARY INFORMATION: 

[[Page 16926]]

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (FD&C 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), 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 FD&C Act (21 U.S.C.360c(i)), to a predicate 
device that does not require premarket approval. The Agency determines 
whether new devices are substantially equivalent to predicate devices 
by means of premarket notification procedures in section 510(k) of the 
FD&C Act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR 
part 807).
    Section 513(f)(2) of the FD&C Act provides that any person who 
submits a premarket notification under section 510(k) of the FD&C Act 
for a device that has not previously been classified may, within 30 
days after receiving an order classifying the device into class III 
under section 513(f)(1) of the FD&C Act, request FDA to classify the 
device under the criteria set forth in section 513(a)(1) of the FD&C 
Act. FDA will, within 60 days of receiving this request, classify the 
device by written order. This classification will 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 this classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an 
order on March 16, 2010, classifying the Infrascanner into 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 April 8, 2010, 
InfraScan, Inc. submitted a petition requesting classification of the 
Infrascanner Model 1000 under section 513(f)(2) of the FD&C Act. The 
manufacturer recommended that the device be classified into class II 
(Ref. 1).
    In accordance with section 513(f)(2) of the FD&C 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 FD&C Act. FDA 
classifies devices 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 device 
can be classified into class II with the establishment of special 
controls. FDA believes these special controls will provide reasonable 
assurance of the safety and effectiveness of the device.
    The device is assigned the generic name Near Infrared (NIR) Brain 
Hematoma Detector, and it is identified as a noninvasive device that 
employs near-infrared spectroscopy that is intended to be used to 
evaluate suspected brain hematomas.
    FDA has identified the following risks to health associated with 
this type of device and the measures required to mitigate these risks:

------------------------------------------------------------------------
            Identified risk                    Mitigation measures
------------------------------------------------------------------------
Excessive laser power..................  Electrical safety and
                                          electromagnetic compatibility
                                          (EMC).
Interference with other devices........  Electrical safety and EMC.
                                         Labeling.
Unit (hardware) malfunction............  Performance testing
                                          (nonclinical and clinical).
                                         Software verification,
                                          validation, and hazard
                                          analysis.
Software malfunction...................  Software verification,
                                          validation, and hazard
                                          analysis.
Operator errors........................  Labeling.
                                         Training.
Incorrect result (false positive and     Labeling.
 negative).
Adverse tissue reaction................  Biocompatibility.
Battery failure (failure of device to    Labeling.
 operate).
------------------------------------------------------------------------

    FDA believes that the following special controls address these 
risks to health and provide reasonable assurance of safety and 
effectiveness: (1) The sale, distribution, and use of this device are 
restricted to prescription use in accordance with 21 CFR 801.109; (2) 
The labeling must include specific instructions and the clinical 
training needed for the safe use of this device; (3) Appropriate 
analysis/testing should validate EMC, electrical safety, and battery 
characteristics; (4) Performance data should validate accuracy and 
precision and safety features; (5) Any elements of the device that may 
contact the patient should be demonstrated to be biocompatible; and (6) 
Appropriate software verification, validation, and hazard analysis 
should be performed. Therefore, on December 13, 2011, FDA issued an 
order to the petitioner classifying the device into class II. FDA is 
codifying the classification of the device by adding Sec.  882.1935.
    Following the effective date of this final classification rule, any 
firm submitting a 510(k) premarket notification for an NIR Brain 
Hematoma Detector will need to comply with the special controls named 
in the regulation.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) of the FD&C 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, FDA has 
determined that premarket notification is necessary to provide 
reasonable assurance of the safety and effectiveness of the device. 
Therefore, this device type is not exempt from premarket notification 
requirements. Persons who intend to market this type of device must 
submit to FDA a premarket notification, prior to marketing the device, 
which contains information about the NIR Brain Hematoma Detector they 
intend to market.

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.

[[Page 16927]]

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct 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 Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because reclassification of this device from class 
III to class II will relieve manufacturers of the device of the cost of 
complying with the premarket approval requirements of section 515 of 
the FD&C 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 
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, 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 $136 million, using the most current (2010) Implicit 
Price Deflator for the Gross Domestic Product. 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. Section 4(a) of the Executive order 
requires Agencies to ``construe * * * a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' Federal law includes an express preemption provision 
that preempts certain State requirements ``different from or in 
addition to'' certain Federal requirements applicable to devices. 21 
U.S.C. 360k; see Medtronic, Inc., v. Lohr, 518 U.S. 470 (1996), and 
Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). The special controls 
established by this final rule create ``requirements'' under 21 U.S.C. 
360(k).

V. Paperwork Reduction Act of 1995

    This final rule establishes special controls that refer to 
currently approved collections of information found in other FDA 
regulations. These collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 
CFR part 807, subpart E regarding premarket notification submissions 
have been approved under OMB control number 0910-0120, and the 
collections of information in 21 CFR part 801 regarding labeling have 
been approved under OMB control number 0910-0485.

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 InfraScan, Inc., April 8, 2010.

List of Subjects in 21 CFR Part 882

    Medical devices, Neurological devices.

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

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for 21 CFR part 882 continues to read as 
follows:

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


0
2. Section 882.1935 is added to subpart B to read as follows:


Sec.  882.1935  Near Infrared (NIR) Brain Hematoma Detector.

    (a) Identification. A Near Infrared (NIR) Brain Hematoma Detector 
is a noninvasive device that employs near-infrared spectroscopy that is 
intended to be used to evaluate suspected brain hematomas.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) The sale, distribution, and use of this device are restricted 
to prescription use in accordance with Sec.  801.109 of this chapter;
    (2) The labeling must include specific instructions and the 
clinical training needed for the safe use of this device;
    (3) Appropriate analysis/testing should validate electromagnetic 
compatibility (EMC), electrical safety, and battery characteristics;
    (4) Performance data should validate accuracy and precision and 
safety features;
    (5) Any elements of the device that may contact the patient should 
be demonstrated to be biocompatible; and,
    (6) Appropriate software verification, validation, and hazard 
analysis should be performed.

    Dated: March 16, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6975 Filed 3-22-12; 8:45 am]
BILLING CODE 4160-01-P


