Document ID: FDA-2020-D-0957-0267
Agency: fda
Document Type: Notice
Title: Compliance Policy Guide Sec. 397.100 Accuracy Requirements for Indication of Temporal-Maximum Ultrasonic Power; Withdrawal of Guidance
Posted Date: 2023-02-21T05:00Z

[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Page 10522]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03509]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0957]

Compliance Policy Guide Sec. 397.100 Accuracy Requirements for 
Indication of Temporal-Maximum Ultrasonic Power; Withdrawal of Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the withdrawal of the compliance policy guide (CPG) Sec. 397.100 
Accuracy Requirements for Indication of Temporal-Maximum Ultrasonic 
Power. The Agency is taking this action because the CPG identified in 
this notice contains policies that have been superseded by a subsequent 
FDA action.

DATES: The withdrawal is effective February 21, 2023.

FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.

SUPPLEMENTARY INFORMATION: We are announcing the withdrawal of the CPG 
entitled ``Compliance Policy Guide Sec. 397.100 Accuracy Requirements 
for Indication of Temporal-Maximum Ultrasonic Power, 21 CFR 
1050.10(c)(1)(ii).'' On January 20, 2023, FDA issued a final rule 
entitled ``Radiological Health Regulations; Amendments to Records and 
Reports for Radiation Emitting Electronic Products; Amendments to 
Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic 
Products'' (88 FR 3638). The final rule repealed 21 CFR 1050.10, which 
includes performance standards for ultrasonic therapy products. 
Therefore, the policies in CPG Sec. 397.100 are no longer applicable, 
and this CPG is being withdrawn.

    Dated: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03509 Filed 2-17-23; 8:45 am]
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