24174 Federal Register / Vol. 87, No. 78 / Friday, April 22, 2022 / Notices 

1See https://www.fda.gov/radiation-emittingproducts/home-business-and-entertainmentproducts/laser-light-shows. 

2See https://www.fda.gov/about-fda/cdrhtransparency/515-program-initiative and https://

www.fda.gov/about-fda/cdrh-transparency/515- 

project-status. 

TABLE 2—CBER GUIDANCES AND COLLECTIONS—Continued 

COVID–19 guidance title CFR cite referenced in 

COVID–19 guidance 

Another guidance title referenced in 

COVID–19 guidance 

OMB control 

No(s). 

21 CFR part 600 ..................................... .................................................................. 0910–0308

21 CFR part 601 ..................................... 0910–0338.

Emergency Use Authorization of Medical 

Products and Related Authorities.

0910–0595 

IV. Electronic Access 

Persons with access to the internet 

may obtain COVID–19-related guidances 

at: 

• FDA web page entitled ‘‘COVID–19- 

Related Guidance Documents for 

Industry, FDA Staff, and Other 

Stakeholders,’’ available at https://

www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19- 

related-guidance-documents-industryfda-staff-and-other-stakeholders; 

• FDA web page entitled ‘‘Search for 

FDA Guidance Documents’’ available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or https://

www.regulations.gov. 

Dated: April 18, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08564 Filed 4–21–22; 8:45 am] 

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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. 

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. 

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. 

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] 

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