Voglio sapere a riguardo di…

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 510k.
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 502f1 of the FD&C Act 21 U.S.C.
352f1 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 25.34b 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. 35013521. 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 09100844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 09100231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 09100120; the collections of information in 21 CFR
part 820, regarding quality system regulation, have been approved under OMB control number 09100073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control number 09100485.

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 882NEUROLOGICAL 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
PO 00000

Frm 00027

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. 202128160 Filed 122821; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Part 882
Docket No. FDA2021N0855

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 systems 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 209930002, 3017962823, 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:FRFM29DER1.SGM

29DER1