Medical Devices; Neurological Devices; Classification of the Diagnostic Neurosurgical Microscope Filter, 73971-73973 [2021-28160]
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Federal Register / Vol. 86, No. 247 / Wednesday, December 29, 2021 / Rules and Regulations
73971
TABLE 1—TRANSCUTANEOUS ELECTRICAL CONTINENCE DEVICE RISKS AND MITIGATION MEASURES
Identified risks
Mitigation measures
Pain or tissue damage due to overstimulation .........................................
Non-clinical performance testing; Software verification, validation, and
hazard analysis; Electrical safety testing; and Labeling.
Biocompatibility evaluation.
Electrical safety testing; Software verification, validation, and hazard
analysis; and Labeling.
Electromagnetic compatibility (EMC) testing; software verification, validation, and hazard analysis; and Labeling.
Software verification, validation, and hazard analysis; and Labeling.
Adverse tissue reaction ............................................................................
Electrical shock or burn ............................................................................
Device failure due to electromagnetic interference ..................................
Use error that may result in user discomfort, injury, or delay in treatment.
FDA has determined that special
controls, in combination with the
general controls, address these risks to
health and provide reasonable assurance
of safety and effectiveness. In order for
a device to fall within this classification,
and thus avoid automatic classification
in class III, it would have to comply
with the special controls named in this
final order. The necessary special
controls appear in the regulation
codified by this order. This device is
subject to premarket notification
requirements under section 510(k) of the
FD&C Act.
III. Analysis of 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.
khammond on DSKJM1Z7X2PROD with RULES
IV. Paperwork Reduction Act of 1995
This final order establishes special
controls that refer to previously
approved collections of information
found in other FDA regulations and
guidance. 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. 3501–3521). The
collections of information in the
guidance document ‘‘De Novo
Classification Process (Evaluation of
Automatic Class III Designation)’’ have
been approved under OMB control
number 0910–0844; the collections of
information in 21 CFR part 814,
subparts A through E, regarding
premarket approval, have been
approved under OMB control number
0910–0231; the collections of
information in part 807, subpart E,
regarding premarket notification
submissions, have been approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 820, regarding quality system
regulation, have been approved under
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OMB control number 0910–0073; and
the collections of information in 21 CFR
part 801, regarding labeling, have been
approved under OMB control number
0910–0485.
List of Subjects in 21 CFR Part 876
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 876 is
amended as follows:
(5) Labeling must include the
following:
(i) Instructions for use, including
specific instructions regarding the
proper placement of electrodes;
(ii) A summary of electrical
stimulation parameters; and
(iii) Cleaning instructions and reuse
information.
Dated: December 16, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–28163 Filed 12–28–21; 8:45 am]
PART 876—GASTROENTEROLOGYUROLOGY DEVICES
BILLING CODE 4164–01–P
■
1. The authority citation for part 876
continues to read as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
Food and Drug Administration
Add § a876.5330 to subpart F to read
as follows:
21 CFR Part 882
■
§ 876.5330 Transcutaneous electrical
continence device.
(a) Identification. A transcutaneous
electrical continence device consists of
cutaneous electrodes that are used to
apply external stimulation to reduce
urinary incontinence.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Non-clinical performance testing
must characterize the electrical
stimulation, including the following:
Waveforms, output modes, maximum
output voltage, maximum output
current, pulse duration, frequency, net
charge per pulse, maximum phase
charge at 500 ohms, maximum current
density, maximum average current, and
maximum average power density.
(2) The patient-contacting materials
must be demonstrated to be
biocompatible.
(3) Performance data must
demonstrate the electromagnetic
compatibility (EMC), electrical safety,
thermal safety, and mechanical safety of
the device.
(4) Software verification, validation,
and hazard analysis must be performed.
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[Docket No. FDA–2021–N–0573]
Medical Devices; Neurological
Devices; Classification of the
Diagnostic Neurosurgical Microscope
Filter
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final amendment; final order.
The Food and Drug
Administration (FDA or we) is
classifying the diagnostic neurosurgical
microscope filter into class II (special
controls). The special controls that
apply to the device type are identified
in this order and will be part of the
codified language for the diagnostic
neurosurgical microscope filter’s
classification. We are taking this action
because we have determined that
classifying the device into class II
(special controls) will provide a
reasonable assurance of safety and
effectiveness of the device. We believe
this action will also enhance patients’
access to beneficial innovative devices.
DATES: This order is effective December
29, 2021. The classification was
applicable on March 28, 2019.
SUMMARY:
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73972
Federal Register / Vol. 86, No. 247 / Wednesday, December 29, 2021 / Rules and Regulations
FOR FURTHER INFORMATION CONTACT:
Daryl Kaufman, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4212, Silver Spring,
MD 20993–0002, 301–796–6467,
Daryl.Kaufman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the
diagnostic neurosurgical microscope
filter as class II (special controls), which
we have determined will provide a
reasonable assurance of safety and
effectiveness. In addition, we believe
this action will enhance patients’ access
to beneficial innovation by placing the
device into a lower device class than the
automatic class III assignment.
The automatic assignment of class III
occurs by operation of law and without
any action by FDA, regardless of the
level of risk posed by the new device.
Any device that was not in commercial
distribution before May 28, 1976, is
automatically classified as, and remains
within, class III and requires premarket
approval unless and until FDA takes an
action to classify or reclassify the device
(see 21 U.S.C. 360c(f)(1)). We refer to
these devices as ‘‘postamendments
devices’’ because they were not in
commercial distribution prior to the
date of enactment of the Medical Device
Amendments of 1976, which amended
the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
FDA may take a variety of actions in
appropriate circumstances to classify or
reclassify a device into class I or II. We
may issue an order finding a new device
to be substantially equivalent under
section 513(i) of the FD&C Act (21
U.S.C. 360c(i)) to a predicate device that
does not require premarket approval.
We determine whether a new device is
substantially equivalent to a predicate
by means of the procedures for
premarket notification under section
510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device
through ‘‘De Novo’’ classification, a
common name for the process
authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and
Drug Administration Modernization Act
of 1997 established the first procedure
for De Novo classification (Pub. L. 105–
115). Section 607 of the Food and Drug
Administration Safety and Innovation
Act modified the De Novo application
process by adding a second procedure
(Pub. L. 112–144). A device sponsor
may utilize either procedure for De
Novo classification.
Under the first procedure, the person
submits a 510(k) for a device that has
not previously been classified. After
receiving an order from FDA classifying
the device into class III under section
513(f)(1) of the FD&C Act, the person
then requests a classification under
section 513(f)(2).
Under the second procedure, rather
than first submitting a 510(k) and then
a request for classification, if the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence, that person requests a
classification under section 513(f)(2) of
the FD&C Act.
Under either procedure for De Novo
classification, FDA is required to
classify the device by written order
within 120 days. The classification will
be according to the criteria under
section 513(a)(1) of the FD&C Act.
Although the device was automatically
within class III, the De Novo
classification is considered to be the
initial classification of the device.
We believe this De Novo classification
will enhance patients’ access to
beneficial innovation. When FDA
classifies a device into class I or II via
the De Novo process, the device can
serve as a predicate for future devices of
that type, including for 510(k)s (see 21
U.S.C. 360c(f)(2)(B)(i)). As a result, other
device sponsors do not have to submit
a De Novo request or premarket
approval application to market a
substantially equivalent device (see 21
U.S.C. 360c(i), defining ‘‘substantial
equivalence’’). Instead, sponsors can use
the less-burdensome 510(k) process,
when necessary, to market their device.
II. De Novo Classification
On April 27, 2018, Leica
Microsystems AG submitted a request
for De Novo classification of the Leica
FL400. FDA reviewed the request in
order to classify the device under the
criteria for classification set forth in
section 513(a)(1) of the FD&C Act.
We classify 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 that, in
combination with the general controls,
provide reasonable assurance of the
safety and effectiveness of the device for
its intended use (see 21 U.S.C.
360c(a)(1)(B)). After review of the
information submitted in the request,
we determined that the device can be
classified into class II with the
establishment of special controls. FDA
has determined that these special
controls, in addition to the general
controls, will provide reasonable
assurance of the safety and effectiveness
of the device.
Therefore, on March 28, 2019, FDA
issued an order to the requester
classifying the device into class II. In
this final order, FDA is codifying the
classification of the device by adding 21
CFR 882.4950.1 We have named the
generic type of device diagnostic
neurosurgical microscope filter, and it is
identified as a device intended for use
during neurosurgery to visualize
fluorescence and enhance visualization
of tissue associated with a specific
disease or condition.
FDA has identified the following risks
to health associated specifically with
this type of device and the measures
required to mitigate these risks in table
1.
TABLE 1—DIAGNOSTIC NEUROSURGICAL MICROSCOPE FILTER RISKS AND MITIGATION MEASURES
khammond on DSKJM1Z7X2PROD with RULES
Identified risks
Mitigation measures
Incorrect or misinterpreted results, including:
• False positive: Visualization of fluorescence when in fact no target fluorophore is present.
• False negative: No visualization of fluorescence when in fact the
target fluorophore is present.
1 FDA notes that the ACTION caption for this
final order is styled as ‘‘Final amendment; final
order,’’ rather than ‘‘Final order.’’ Beginning in
December 2019, this editorial change was made to
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Non-clinical performance testing, and Labeling.
indicate that the document ‘‘amends’’ the Code of
Federal Regulations. The change was made in
accordance with the Office of Federal Register’s
(OFR) interpretations of the Federal Register Act (44
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
U.S.C. chapter 15), its implementing regulations (1
CFR 5.9 and parts 21 and 22), and the Document
Drafting Handbook.
E:\FR\FM\29DER1.SGM
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Federal Register / Vol. 86, No. 247 / Wednesday, December 29, 2021 / Rules and Regulations
FDA has determined that special
controls, in combination with the
general controls, address these risks to
health and provide reasonable assurance
of safety and effectiveness. In order for
a device to fall within this classification,
and thus avoid automatic classification
in class III, it would have to comply
with the special controls named in this
final order. The necessary special
controls appear in the regulation
codified by this order. This device is
subject to premarket notification
requirements under section 510(k).
At the time of classification,
diagnostic neurosurgical microscope
filters are for prescription use only.
Prescription devices are exempt from
the requirement for adequate directions
for use for the layperson under section
502(f)(1) of the FD&C Act (21 U.S.C.
352(f)(1)) and 21 CFR 801.5, as long as
the conditions of 21 CFR 801.109 are
met.
III. Analysis of 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.
khammond on DSKJM1Z7X2PROD with RULES
IV. Paperwork Reduction Act of 1995
This final order establishes special
controls that refer to previously
approved collections of information
found in other FDA regulations and
guidance. 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. 3501–3521). The
collections of information in the
guidance document ‘‘De Novo
Classification Process (Evaluation of
Automatic Class III Designation)’’ have
been approved under OMB control
number 0910–0844; the collections of
information in 21 CFR part 814,
subparts A through E, regarding
premarket approval, have been
approved under OMB control number
0910–0231; the collections of
information in part 807, subpart E,
regarding premarket notification
submissions, have been approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 820, regarding quality system
regulation, have been approved under
OMB control number 0910–0073; and
the collections of information in 21 CFR
part 801, regarding labeling, have been
approved under OMB control number
0910–0485.
VerDate Sep<11>2014
16:59 Dec 28, 2021
Jkt 256001
List of Subjects in 21 CFR Part 882
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 882 is
amended as follows:
PART 882—NEUROLOGICAL DEVICES
1. The authority citation for part 882
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Add § 882.4950 to subpart E to read
as follows:
■
§ 882.4950 Diagnostic neurosurgical
microscope filter.
(a) Identification. A diagnostic
neurosurgical microscope filter is a
device intended for use during
neurosurgery to visualize fluorescence
and enhance visualization of tissue
associated with a specific disease or
condition.
(b) Classification. Class II (special
controls). The special controls for this
device are:
(1) Non-clinical performance testing
must demonstrate that the device
performs as intended under anticipated
conditions of use, and verify and
validate filter specifications and
functional characteristics, including the
following:
(i) Spectrum and intensity of the
illumination source;
(ii) Spectrum of the excitation and
emission filter modules when integrated
in the surgical operating microscope;
(iii) Excitation power and power
density;
(iv) Optical path loss from
illumination source to objective lens or
microscope camera;
(v) Homogeneity of the excitation
light at the focal plane;
(vi) Fluorescence detection
sensitivity;
(vii) Verification of calibration or
preoperative procedures; and
(viii) If camera-based, spectral
sensitivity of the camera.
(2) Labeling must include:
(i) Identification of the filter
characteristics in conjunction with a
compatible surgical operating
microscope, to include the following:
(A) Illumination spectrum and power
density; and
(B) Excitation and emission filter
spectra.
(ii) Instructions for calibration or
preoperative checks to ensure device
functionality prior to each use;
(iii) Instructions for use with
compatible surgical operating
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Fmt 4700
Sfmt 4700
73973
microscopes, external light sources, and
cameras;
(iv) A warning that the device should
only be used with fluorophores
approved for use within the specified
spectral ranges; and
(v) A warning that the device is not
a standalone diagnostic.
Dated: December 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–28160 Filed 12–28–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA–2021–N–0855]
Medical Devices; Neurological
Devices; Classification of the
Cerebrospinal Fluid Shunt System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final amendment; final order.
The Food and Drug
Administration (FDA or we) is
classifying the cerebrospinal fluid shunt
system into class II (special controls).
The special controls that apply to the
device type are identified in this order
and will be part of the codified language
for the cerebrospinal fluid shunt
system’s classification. We are taking
this action because we have determined
that classifying the device into class II
(special controls) will provide a
reasonable assurance of safety and
effectiveness of the device. We believe
this action will also enhance patients’
access to beneficial innovative devices.
DATES: This order is effective December
29, 2021. The classification was
applicable on August 22, 2014.
FOR FURTHER INFORMATION CONTACT:
Xiaolin Zheng, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2674, Silver Spring,
MD 20993–0002, 301–796–2823,
Xiaolin.Zheng@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Upon request, FDA has classified the
cerebrospinal fluid shunt system as
class II (special controls), which we
have determined will provide a
reasonable assurance of safety and
effectiveness. In addition, we believe
this action will enhance patients’ access
to beneficial innovation.
E:\FR\FM\29DER1.SGM
29DER1
Agencies
[Federal Register Volume 86, Number 247 (Wednesday, December 29, 2021)]
[Rules and Regulations]
[Pages 73971-73973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-28160]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA-2021-N-0573]
Medical Devices; Neurological Devices; Classification of the
Diagnostic Neurosurgical Microscope Filter
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; final order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the diagnostic neurosurgical microscope filter into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the diagnostic neurosurgical microscope filter's classification. We are
taking this action because we have determined that classifying the
device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices.
DATES: This order is effective December 29, 2021. The classification
was applicable on March 28, 2019.
[[Page 73972]]
FOR FURTHER INFORMATION CONTACT: Daryl Kaufman, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4212, Silver Spring, MD 20993-0002, 301-796-6467,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the diagnostic neurosurgical
microscope filter as class II (special controls), which we have
determined will provide a reasonable assurance of safety and
effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation by placing the device into a
lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically within
class III, the De Novo classification is considered to be the initial
classification of the device.
We believe this De Novo classification will enhance patients'
access to beneficial innovation. When FDA classifies a device into
class I or II via the De Novo process, the device can serve as a
predicate for future devices of that type, including for 510(k)s (see
21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not
have to submit a De Novo request or premarket approval application to
market a substantially equivalent device (see 21 U.S.C. 360c(i),
defining ``substantial equivalence''). Instead, sponsors can use the
less-burdensome 510(k) process, when necessary, to market their device.
II. De Novo Classification
On April 27, 2018, Leica Microsystems AG submitted a request for De
Novo classification of the Leica FL400. FDA reviewed the request in
order to classify the device under the criteria for classification set
forth in section 513(a)(1) of the FD&C Act.
We classify 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 that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on March 28, 2019, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
882.4950.\1\ We have named the generic type of device diagnostic
neurosurgical microscope filter, and it is identified as a device
intended for use during neurosurgery to visualize fluorescence and
enhance visualization of tissue associated with a specific disease or
condition.
---------------------------------------------------------------------------
\1\ FDA notes that the ACTION caption for this final order is
styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------
FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.
Table 1--Diagnostic Neurosurgical Microscope Filter Risks and Mitigation
Measures
------------------------------------------------------------------------
Identified risks Mitigation measures
------------------------------------------------------------------------
Incorrect or misinterpreted results, Non-clinical performance
including: testing, and Labeling.
False positive:
Visualization of fluorescence when
in fact no target fluorophore is
present.
False negative: No
visualization of fluorescence when
in fact the target fluorophore is
present.
------------------------------------------------------------------------
[[Page 73973]]
FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k).
At the time of classification, diagnostic neurosurgical microscope
filters are for prescription use only. Prescription devices are exempt
from the requirement for adequate directions for use for the layperson
under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21
CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.
III. Analysis of 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. Paperwork Reduction Act of 1995
This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. 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. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.
List of Subjects in 21 CFR Part 882
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 882 is amended as follows:
PART 882--NEUROLOGICAL DEVICES
0
1. The authority citation for part 882 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
0
2. Add Sec. 882.4950 to subpart E to read as follows:
Sec. 882.4950 Diagnostic neurosurgical microscope filter.
(a) Identification. A diagnostic neurosurgical microscope filter is
a device intended for use during neurosurgery to visualize fluorescence
and enhance visualization of tissue associated with a specific disease
or condition.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use, and
verify and validate filter specifications and functional
characteristics, including the following:
(i) Spectrum and intensity of the illumination source;
(ii) Spectrum of the excitation and emission filter modules when
integrated in the surgical operating microscope;
(iii) Excitation power and power density;
(iv) Optical path loss from illumination source to objective lens
or microscope camera;
(v) Homogeneity of the excitation light at the focal plane;
(vi) Fluorescence detection sensitivity;
(vii) Verification of calibration or preoperative procedures; and
(viii) If camera-based, spectral sensitivity of the camera.
(2) Labeling must include:
(i) Identification of the filter characteristics in conjunction
with a compatible surgical operating microscope, to include the
following:
(A) Illumination spectrum and power density; and
(B) Excitation and emission filter spectra.
(ii) Instructions for calibration or preoperative checks to ensure
device functionality prior to each use;
(iii) Instructions for use with compatible surgical operating
microscopes, external light sources, and cameras;
(iv) A warning that the device should only be used with
fluorophores approved for use within the specified spectral ranges; and
(v) A warning that the device is not a standalone diagnostic.
Dated: December 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-28160 Filed 12-28-21; 8:45 am]
BILLING CODE 4164-01-P