Rule2021-28160
Medical Devices; Neurological Devices; Classification of the Diagnostic Neurosurgical Microscope Filter
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 29, 2021
Effective
December 29, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 247 (Wednesday, December 29, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-28160]
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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.
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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,
<a href="/cdn-cgi/l/email-protection#3e7a5f4c475210755f4b58535f507e585a5f1056564d10595148"><span class="__cf_email__" data-cfemail="d094b1a2a9bcfe9bb1a5b6bdb1be90b6b4b1feb8b8a3feb7bfa6">[email protected]</span></a>.
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.
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\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.
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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
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Identified risks Mitigation measures
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Incorrect or misinterpreted results, Non-clinical performance
including: testing, and Labeling.
<bullet> False positive:
Visualization of fluorescence when
in fact no target fluorophore is
present.
<bullet> False negative: No
visualization of fluorescence when
in fact the target fluorophore is
present.
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[[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
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