Notice2022-08587
Compliance Policy Guides Sec. 335.500; Sec. 310.200; Sec. 393.100; Sec. 398.425; Sec. 394.500; Sec. 300.750; Withdrawal of Guidance
Primary source
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Published
April 22, 2022
Effective
April 22, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of six compliance policy guides (CPG). The Agency is taking this action because the CPGs identified in this notice contain information that is either duplicative of other information the Agency has published or no longer reflects the Agency's current thinking.
Full Text
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<title>Federal Register, Volume 87 Issue 78 (Friday, April 22, 2022)</title>
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[Federal Register Volume 87, Number 78 (Friday, April 22, 2022)]
[Notices]
[Page 24174]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08587]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-0957]
Compliance Policy Guides Sec. 335.500; Sec. 310.200; Sec.
393.100; Sec. 398.425; Sec. 394.500; Sec. 300.750; 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 six compliance policy guides (CPG). The Agency is
taking this action because the CPGs identified in this notice contain
information that is either duplicative of other information the Agency
has published or no longer reflects the Agency's current thinking.
DATES: The withdrawal is effective April 22, 2022.
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:
After careful review of CPGs related to device products, FDA has
identified the following six CPGs, that contain information that is
either duplicative or no longer reflects the Agency's current thinking.
FDA originally issued CPG Sec. 335.500, ``Razor Blades, Manicuring
Instruments--Not Considered Devices Under 201(h)'' (CPG Sec. 335.500)
in April 1976. The CPG was revised periodically but has not been
revised since March 1995. Given the time that has passed since the last
revision of CPG Sec. 335.500, upon further review, FDA has determined
that while the CPG still reflects the Agency's current thinking, it is
no longer needed because it appears to be seldomly accessed.
CPG Sec. 310.200, ``Sphygmomanometers--Rx Legend'' (CPG Sec.
310.200) was originally issued in January 1973. The CPG was revised
periodically but has not been revised since September 1987. Since CPG
Sec. 310.200 was last updated, many of these products have been cleared
to be sold over the counter and therefore, the policy contained in this
CPG is obsolete and no longer needed.
CPG Sec. 393.100, ``Enforcement Policy for Certain Laser Light
Shows, Displays, and/or Devices. (21 CFR 1040.10 and 1040.11)'' (CPG
Sec 393.100) was originally issued in October 1980. The CPG was revised
periodically but has not been revised since March 2005. Since CPG Sec.
393.100 was last revised, the policies regarding these products have
been updated and additional resources have been made available to the
public regarding these products, including in four laser notice
guidance documents.\1\ The change in policies and the availability of
additional resources has resulted in the information contained within
CPG Sec. 393.100 to be duplicative and outdated.
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\1\ See <a href="https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-light-shows">https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-light-shows</a>.
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CPG Sec. 398.425, ``Override of Positive Beam Limitation--21 CFR
1020.31(g)(5)'' (CPG Sec. 398.425) was originally issued in October
1980. The CPG was revised periodically but has not been revised since
March 2005. Given the time that has passed since the last revision of
CPG Sec. 398.425, upon further review, FDA has determined that the CPG
provides duplicative information to what is provided in 21 CFR
1020.31(g)(5).
CPG Sec. 394.500, ``Importation of Television Products, Microwave
Ovens, and Inherent Class I Laser Products for Investigation and
Evaluation during Design Development'' (CPG Sec. 394.500) was
originally issued in March 1984. The CPG was revised periodically but
has not been revised since July 2004. Given the time that has passed
since the last revision of CPG Sec. 394.500, upon further review, FDA
has determined that the CPG contains outdated information and
references.
Finally, CPG Sec. 300.750, ``Class III Devices Subject to 515(b)
Requirements'' (CPG Sec. 300.750) was originally issued in October
1990. The CPG was revised periodically but has not been revised since
July 2005. Since CPG Sec. 300.750 was last revised, FDA has completed
the actions for the preamendment class III devices discussed in the CPG
to either reclassify them into class I, or II, or, if retaining the
device in class III, calling for PMAs; \2\ as such, the CPG is
obsolete.
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\2\ See <a href="https://www.fda.gov/about-fda/cdrh-transparency/515-program-initiative">https://www.fda.gov/about-fda/cdrh-transparency/515-program-initiative</a> and <a href="https://www.fda.gov/about-fda/cdrh-transparency/515-project-status">https://www.fda.gov/about-fda/cdrh-transparency/515-project-status</a>.
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Therefore, after careful review, FDA is withdrawing CPG Sec.
335.500, CPG Sec. 310.200, 393.100, CPG Sec. 398.425, CPG Sec. 394.500,
and CPG Sec. 300.750 in their entirety because the CPGs are either
obsolete or contain duplicative information.
Dated: April 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08587 Filed 4-21-22; 8:45 am]
BILLING CODE 4164-01-P
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