Voglio sapere a riguardo di…

Federal Register / Vol. 86, No. 247 / Wednesday, December 29, 2021 / Rules and Regulations
73971

TABLE 1TRANSCUTANEOUS 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 510k of the FD&C Act.
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
VerDate Sep<11>2014

16:59 Dec 28, 2021

Jkt 256001

OMB control number 09100073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control number 09100485.
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. 202128163 Filed 122821; 8:45 am
PART 876GASTROENTEROLOGYUROLOGY DEVICES

BILLING CODE 416401P

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.

PO 00000

Frm 00025

Fmt 4700

Sfmt 4700

Docket No. FDA2021N0573

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 filters 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:

E:FRFM29DER1.SGM

29DER1