32988 Federal Register / Vol. 87, No. 105 / Wednesday, June 1, 2022 / Rules and Regulations 

SUPPLEMENT NO. 4 TO PART 744—ENTITY LIST—Continued 

Country Entity License 

requirement 

License 

review policy 

Federal Register 

citation 

Kaliningradnefteprodukt OOO, a.k.a., 

the following three aliases: 

—Kaliningradnefteprodukt LLC; 

—Limited Liability Company 

Kaliningradnefteproduct; and 

—LLC Kaliningradnefteproduct 

For all items subject to 

the EAR when used in 

projects specified in 

§ 746.5 of the EAR.

Presumption of denial ...... 83 FR 6952, 2/16/18. 83 

FR 12479, 3/22/18. 

22–b Komsomolskaya Ulitsa, Central 

District, Kaliningrad, Russia. 

*******

[FR Doc. 2022–11614 Filed 5–31–22; 8:45 am] 

BILLING CODE 099–10–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1225 

Safety Standard for Hand-Held Infant 

Carriers 

CFR Correction 

This rule is being published by the 

Office of the Federal Register to correct 

an editorial or technical error that 

appeared in the most recent annual 

revision of the Code of Federal 

Regulations. 

■ In Title 16 of the Code of Federal 

Regulations, Part 1000 to End, revised as 

of January 1, 2022, in § 1225.2, add 

‘‘email: cpsc-os@cpsc.gov,’’ in the fifth 

sentence after the telephone number 

‘‘301–504–7479’’. 

[FR Doc. 2022–11615 Filed 5–31–22; 8:45 am] 

BILLING CODE 0099–10–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 870 

[Docket No. FDA–2022–N–0713] 

Medical Devices; Cardiovascular 

Devices; Classification of the Coronary 

Artery Disease Risk Indicator Using 

Acoustic Heart Signals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the coronary artery disease 

risk indicator using acoustic heart 

signals into class II (special controls). 

The special controls that apply to the 

device type are identified in this order 

and will be part of the codified language 

for the coronary artery disease risk 

indicator using acoustic heart signals’ 

classification. We are taking this action 

because we have determined that 

classifying the device into class II 

(special controls) will provide a 

reasonable assurance of safety and 

effectiveness of the device. We believe 

this action will also enhance patients’ 

access to beneficial innovative devices. 

DATES: This order is effective June 1, 

2022. The classification was applicable 

on November 24, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Crowley, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2531, Silver Spring, 

MD, 20993–0002, 301–796–6017, 

Kimberly.Crowley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

coronary artery disease risk indicator 

using acoustic heart signals as class II 

(special controls), which we have 

determined will provide a reasonable 

assurance of safety and effectiveness. In 

addition, we believe this action will 

enhance patients’ access to beneficial 

innovation, in part by placing the device 

into a lower device class than the 

automatic class III assignment. 

The automatic assignment of class III 

occurs by operation of law and without 

any action by FDA, regardless of the 

level of risk posed by the new device. 

Any device that was not in commercial 

distribution before May 28, 1976, is 

automatically classified as, and remains 

within, class III and requires premarket 

approval unless and until FDA takes an 

action to classify or reclassify the device 

(see 21 U.S.C. 360c(f)(1)). We refer to 

these devices as ‘‘postamendments 

devices’’ because they were not in 

commercial distribution prior to the 

date of enactment of the Medical Device 

Amendments of 1976, which amended 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

FDA may take a variety of actions in 

appropriate circumstances to classify or 

reclassify a device into class I or II. We 

may issue an order finding a new device 

to be substantially equivalent under 

section 513(i) of the FD&C Act (see 21 

U.S.C. 360c(i)) to a predicate device that 

does not require premarket approval. 

We determine whether a new device is 

substantially equivalent to a predicate 

device by means of the procedures for 

premarket notification under section 

510(k) of the FD&C Act (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807). 

FDA may also classify a device 

through ‘‘De Novo’’ classification, a 

common name for the process 

authorized under section 513(f)(2) of the 

FD&C Act. Section 207 of the Food and 

Drug Administration Modernization Act 

of 1997 (Pub. L. 105–115) established 

the first procedure for De Novo 

classification. Section 607 of the Food 

and Drug Administration Safety and 

Innovation Act (Pub. L. 112–144) 

modified the De Novo application 

process by adding a second procedure. 

A device sponsor may utilize either 

procedure for De Novo classification. 

Under the first procedure, the person 

submits a 510(k) for a device that has 

not previously been classified. After 

receiving an order from FDA classifying 

the device into class III under section 

513(f)(1) of the FD&C Act, the person 

then requests a classification under 

section 513(f)(2). 

Under the second procedure, rather 

than first submitting a 510(k) and then 

a request for classification, if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence, that person requests a 

classification under section 513(f)(2) of 

the FD&C Act. 

Under either procedure for De Novo 

classification, FDA is required to 

classify the device by written order 


jspears on DSK121TN23PROD with RULES1