26996 Federal Register / Vol. 87, No. 88 / Friday, May 6, 2022 / Rules and Regulations 

(ii) A statement in the labeling that 

the safety and effectiveness of the 

device has not been evaluated for 

outcomes related to the treatment or 

prevention of cancer, including but not 

limited to risk reduction, overall 

survival, disease-free survival and local 

recurrence, unless FDA determines that 

it can be removed or modified based on 

clinical performance data submitted to 

FDA; 

(iii) Identification of compatible 

devices; 

(iv) The list of surgical procedures for 

which the device has been determined 

to be safe with clinical justification; 

(v) Reprocessing instructions for 

reusable components; 

(vi) A shelf life for any sterile 

components; 

(vii) A description of the devicespecific use training program; 

(viii) A statement that the device is 

only for distribution to facilities that 

implement and maintain the devicespecific use training program and 

ensure that users of the device have 

completed the device-specific use 

training program; and 

(ix) A detailed summary of the postmarket surveillance data collected 

under paragraph (b)(3) of this section 

and any necessary modifications to the 

labeling to accurately reflect outcomes 

based upon the post-market surveillance 

data collected under paragraph (b)(3) of 

this section. 

(6) Clinical performance testing must 

demonstrate that the device performs as 

intended under anticipated conditions 

of use. 

(7) Human factors validation testing 

must be performed and must 

demonstrate that the user interfaces of 

the system support safe use in an 

operating room environment. 

(8) Non-clinical performance testing 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use and must include: 

(i) Device motion accuracy and 

precision; 

(ii) System testing; 

(iii) Instrument reliability; 

(iv) Thermal effects on tissue; 

(v) Human-device interface; 

(vi) Mounting hardware testing; 

(vii) Workspace access testing; and 

(viii) Performance testing with 

compatible devices. 

(9) Software verification, validation, 

and hazard analysis must be performed. 

Software documentation must include 

an assessment of the impact of threats 

and vulnerabilities on device 

functionality and end users/patients as 

part of cybersecurity review. 

(10) Electromagnetic compatibility 

and electrical, thermal, and mechanical 

safety testing must be performed. 

(11) Performance data must 

demonstrate the sterility of all patientcontacting device components. 

(12) Performance data must support 

the shelf life of the device components 

provided sterile by demonstrating 

continued sterility and package integrity 

over the labeled shelf life. 

(13) Performance data must validate 

the reprocessing instructions for the 

reusable components of the device. 

(14) Performance data must 

demonstrate that all patient-contacting 

components of the device are 

biocompatible. 

(15) Performance data must 

demonstrate that all patient-contacting 

components of the device are nonpyrogenic. 

Dated: April 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09749 Filed 5–5–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[Docket No. USCG–2022–0227] 

Special Local Regulation; Crystal Pier 

Outrigger Race, San Diego, CA 

AGENCY: Coast Guard, Department of 

Homeland Security (DHS). 

ACTION: Notification of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

the Crystal Pier Outrigger Race special 

local regulations on the waters of 

Mission Bay, California, on May 7, 2022. 

These special local regulations are 

necessary to provide for the safety of the 

participants, crew, spectators, sponsor 

vessels, and general users of the 

waterway. During the enforcement 

period, persons and vessels are 

prohibited from anchoring, blocking, 

loitering, or impeding within this 

regulated area unless authorized by the 

Captain of the Port, or his designated 

representative. 

DATES: The regulations in 33 CFR 

100.1101 will be enforced from 7 a.m. 

through 5 p.m. on May 7, 2022, for the 

locations described in Item No. 14 in 

Table 1 to § 100.1101. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

email Lieutenant Commander John 

Santorum, Waterways Management, 

U.S. Coast Guard Sector San Diego, CA; 

telephone 619–278–7656, email 

MarineEventsSD@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the special local 

regulations in 33 CFR 100.1101 for the 

Crystal Pier Outrigger Race in Mission 

Bay, CA in 33 CFR 100.1101, for the 

locations described in Item No. 14 in 

Table 1 to that section from 7 a.m. until 

5 p.m. on May 7, 2022. This 

enforcement action is being taken to 

provide for the safety of life on 

navigable waterways during the event. 

The Coast Guard’s regulation for 

recurring marine events in the San 

Diego Captain of the Port Zone 

identifies the regulated entities and area 

for this event. Under the provisions of 

33 CFR 100.1101, persons and vessels 

are prohibited from anchoring, blocking, 

loitering, or impeding within this 

regulated area, unless authorized by the 

Captain of the Port, or his designated 

representative. The Coast Guard may be 

assisted by other Federal, State, or local 

law enforcement agencies in enforcing 

this regulation. 

In addition to this document in the 

Federal Register, the Coast Guard will 

provide the maritime community with 

advance notification of this enforcement 

period via the Local Notice to Mariners, 

marine information broadcasts, and 

local advertising by the event sponsor. 

If the Captain of the Port Sector San 

Diego or his designated representative 

determines that the regulated area need 

not be enforced for the full duration 

stated on this document, he or she may 

use a Broadcast Notice to Mariners or 

other communications coordinated with 

the event sponsor to grant general 

permission to enter the regulated area. 

Dated: May 2, 2022. 

T.J. Barelli, 

Captain, U.S. Coast Guard, Captain of the 

Port San Diego. 

[FR Doc. 2022–09722 Filed 5–5–22; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket Number USCG–2022–0190] 

RIN 1625–AA00 

Safety Zone; Sabine River, Orange, TX 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone for 

certain navigable waters of the Sabine 


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