[Federal Register Volume 87, Number 78 (Friday, April 22, 2022)]
[Notices]
[Page 24174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08587]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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CPG is obsolete and no longer needed.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.
---------------------------------------------------------------------------

    \1\ See https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-light-shows.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \2\ See https://www.fda.gov/about-fda/cdrh-transparency/515-program-initiative and https://www.fda.gov/about-fda/cdrh-transparency/515-project-status.
---------------------------------------------------------------------------

    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