Compliance Policy Guide Sec. 397.100 Accuracy Requirements for Indication of Temporal-Maximum Ultrasonic Power; Withdrawal of Guidance
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Abstract
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 The Agency is taking this action because the CPG identified in this notice contains policies that have been superseded by a subsequent FDA action.
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<title>Federal Register, Volume 88 Issue 34 (Tuesday, February 21, 2023)</title>
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[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Page 10522]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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this notice contains policies that have been superseded by a subsequent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]
BILLING CODE 4164-01-P
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