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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Rules and Regulations 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.
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.
List of Subjects in 21 CFR Part 888
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 888 is amended as follows:

Intraoperative orthopedic strain
a Identification. A strain sensor device is an adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only. The device is not intended to provide diagnostic information or influence clinical decision making.
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. The following performance testing must be conducted:
i Mechanical testing to evaluate the effect of the device on the mechanical performance of the implant and to characterize the mechanical limits of the components used with the implant; and ii Accuracy and repeatability testing of strain measurements.
2 Usability testing must evaluate the effect of the device on the performance of the surgical procedure.
3 The patient-contacting components of the device must be demonstrated to be biocompatible.
4 Performance testing must support the sterility and shelf life of the patientcontacting components of the device.
5 Software verification, validation, and hazard analysis must be performed.
6 Performance data must validate the reprocessing instructions for reusable components of the device.
7 Performance data must be provided to demonstrate the electromagnetic compatibility EMC
and electrical safety of the device.
8 Labeling must include the following:
i A shelf life;
ii Instructions for use;
iii Reprocessing instructions for any reusable components; and iv A statement that the device is not intended to provide diagnostic information or influence clinical decision making.
Dated: November 29, 2021.
Lauren K. Roth, Associate Commissioner for Policy.

PART 888ORTHOPEDIC DEVICES
lotter on DSK11XQN23PROD with RULES1

888.3090
sensor.

1. The authority citation for part 888
continues to read as follows:

FR Doc. 202126183 Filed 12121; 8:45 am
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

BILLING CODE 416401P

2. Add 888.3090 to subpart D to read as follows:

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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard 33 CFR Part 100
Docket No. USCG20210879

Special Local Regulations; Charleston Parade of Boats, Charleston, SC
Coast Guard, DHS.
Notification of enforcement of regulation.

AGENCY:
ACTION:

The Coast Guard will enforce the special local regulation for the Charleston Parade of Boats on December 11, 2021. This action is necessary to ensure safety of life on navigable waters of the United States during the Charleston Parade of Boats. During the enforcement period, no person or vessel may enter, transit through, anchor in, or remain within the designated area unless authorized by the Captain of the Port Charleston COTP or a designated representative.
DATES: The regulations in 33 CFR
100.704, Table 1 to 100.704, Item No.
10, will be enforced from 4:00 p.m. until 8:30 p.m. on December 11, 2021.
FOR FURTHER INFORMATION CONTACT: If you have questions about this notice of enforcement, call or email LCDR Chad Ray, Sector Charleston Office of Waterways Management, Coast Guard;
telephone 843 7403184, email Chad.L.Ray@uscg.mil.
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special local regulation in 33 CFR 100.704, Item No.
10, for the Charleston Parade of Boats from 4:00 p.m. through 8:30 p.m. on December 11, 2021. This action is being taken to provide for the safety of life on navigable waterways during this event.
Our regulation for marine events within the Seventh Coast Guard District 100.704, Item No. 10, specifies the location of the regulated area for the Charleston Parade of Boats, which encompasses a portion of the waterways during the parade transit from Charleston Harbor Anchorage A through Shutes Folly, Bennis Reach, Horse Reach, Hog Island Reach, Town Creek Lower Reach, Ashley River, and finishing at City Marina. During the enforcement period, if you are the operator of a vessel in the regulated area you must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.
In addition to this notice of enforcement in the Federal Register, the Coast Guard plans to provide notification of this enforcement period SUMMARY:

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