75602 Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Notices 

21 CFR part; guidance; or FDA form Topic OMB control 

No. 

807, subpart E ............................................................................ Premarket notification ................................................................. 0910–0120 

‘‘Requests for Feedback and Meetings for Medical Device 

Submissions: The Q-Submission Program’’.

Q-Submissions and Early Payor Feedback Request Programs 

for Medical Devices.

0910–0756 

800, 801, 809, and 830 .............................................................. Medical Device Labeling Requirements; Unique Device Identification.0910–0485 

806 .............................................................................................. Medical Devices; Reports of Corrections and Removals .......... 0910–0359 

807, subparts A through D ......................................................... Medical Device Registration and Listing .................................... 0910–0625 

820 .............................................................................................. Current Good Manufacturing Practice, Quality Systems ........... 0910–0073 

Dated: October 31, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–24291 Filed 11–2–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4372] 

Medical Devices; Exemptions From 

Premarket Notification: Class II 

Devices; Clinical Electronic 

Thermometers; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

identified certain class II clinical 

electronic thermometers that, when 

finalized, will be exempt from 

premarket notification requirements, 

subject to certain limitations. FDA is 

publishing this notice of that 

determination and requesting public 

comment in accordance with the 

procedures established by the 21st 

Century Cures Act. FDA will review any 

comments submitted within the 60-day 

comment period and will consider 

whether any modifications should be 

made to the exemption for certain 

clinical electronic thermometers prior to 

publication of its final determination in 

the Federal Register. 

DATES: Either electronic or written 

comments on the notice must be 

submitted by January 2, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

January 2, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–N–4372 for ‘‘Medical Devices; 

Exemptions from Premarket 

Notification: Class II Devices; Clinical 

Electronic Thermometers; Request for 

Comments.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015-

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Madhusoodana Nambiar, Center for 

Devices and Radiological Health, Food 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Notices 75603 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5519, 

Silver Spring, MD 20993, 301–796– 

5837, Madhusoodana.Nambiar@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under section 513 of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 360c), FDA must classify 

devices into one of three regulatory 

classes: class I, class II, or class III. FDA 

classification of a device is determined 

by the amount of regulation necessary to 

provide a reasonable assurance of safety 

and effectiveness. Under the Medical 

Device Amendments of 1976 (1976 

amendments) (Pub. L. 94–295), and the 

amendments of the Safe Medical 

Devices Act of 1990 (Pub. L. 101–629), 

devices are to be classified into class I 

(general controls) if there is information 

showing that the general controls of the 

FD&C Act are sufficient to assure safety 

and effectiveness; into class II (special 

controls), if general controls, by 

themselves, are insufficient to provide 

reasonable assurance of safety and 

effectiveness, but there is sufficient 

information to establish special controls 

to provide such assurance; and into 

class III (premarket approval), if there is 

insufficient information to support 

classifying a device into class I or class 

II and the device is a life sustaining or 

life supporting device or is for a use 

which is of substantial importance in 

preventing impairment of human health 

or presents a potential unreasonable risk 

of illness or injury. 

Most generic types of devices that 

were on the market before the date of 

the 1976 amendments (May 28, 1976) 

(generally referred to as preamendments 

devices) have been classified by FDA 

under the procedures set forth in section 

513(c) and (d) of the FD&C Act through 

the issuance of classification regulations 

into one of these three regulatory 

classes. Devices introduced into 

interstate commerce for the first time on 

or after May 28, 1976 (generally referred 

to as postamendments devices) are 

classified through the premarket 

notification process under section 

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

360(k)). Section 510(k) of the FD&C Act 

and the implementing regulations, part 

807 of Title 21 of the Code of Federal 

Regulations (CFR), require persons who 

intend to market a new device to submit 

a premarket notification (510(k)) 

containing information that allows FDA 

to determine whether the new device is 

‘‘substantially equivalent’’ within the 

meaning of section 513(i) of the FD&C 

Act to a legally marketed device that 

does not require premarket approval. 

The 21st Century Cures Act (Cures 

Act) (Pub. L. 114–255) was signed into 

law on December 13, 2016. Section 3054 

of the Cures Act amended section 

510(m) of the FD&C Act. As amended, 

section 510(m)(1)(A) of the FD&C Act 

requires FDA to publish in the Federal 

Register a notice containing a list of 

each type of class II device that FDA 

determines no longer requires a report 

under section 510(k) of the FD&C Act to 

provide reasonable assurance of safety 

and effectiveness. FDA is required to 

publish this notice within 90 days of the 

date of enactment of the Cures Act and 

at least once every 5 years thereafter, as 

FDA determines appropriate. 

Additionally, FDA must provide at least 

a 60-day comment period for any such 

notice published under section 

510(m)(1)(A) of the FD&C Act. 

FDA published the initial notice 

within the 90-day time frame in the 

Federal Register of March 14, 2017 (82 

FR 13609) and issued its final 

determination of exemption of the 

devices in such notice in accordance 

with section 510(m)(1)(B) of the FD&C 

Act in the Federal Register of July 11, 

2017 (82 FR 31976). FDA is publishing 

this notice and requesting public 

comment in accordance with section 

510(m)(1)(A) of the FD&C Act. In a 

future final action, and after considering 

comments, FDA intends to amend the 

codified language in the clinical 

electronic thermometer regulation to 

reflect the final determination with 

respect to exemption. 

II. Factors FDA May Consider for 

Exemption 

There are a number of factors FDA 

may consider to determine whether a 

510(k) is necessary to provide 

reasonable assurance of the safety and 

effectiveness of a class II device. These 

factors are discussed in the January 21, 

1998, Federal Register notice (63 FR 

3142) and subsequently in the guidance 

the Agency issued on February 19, 1998, 

entitled ‘‘Procedures for Class II Device 

Exemptions from Premarket 

Notification, Guidance for Industry and 

CDRH Staff’’ (‘‘Class II 510(k) 

Exemption Guidance’’) (Ref. 1). 

Accordingly, FDA generally considers 

the following factors to determine 

whether premarket notification is 

necessary for class II devices: (1) the 

device does not have a significant 

history of false or misleading claims or 

of risks associated with inherent 

characteristics of the device; (2) 

characteristics of the device necessary 

for its safe and effective performance are 

well established; (3) changes in the 

device that could affect safety and 

effectiveness will either (a) be readily 

detectable by users by visual 

examination or other means such as 

routine testing, before causing harm, or 

(b) not materially increase the risk of 

injury, incorrect diagnosis, or ineffective 

treatment; and (4) any changes to the 

device would not be likely to result in 

a change in the device’s classification. 

FDA may also consider that, even when 

exempting devices, these devices would 

still be subject to the limitations on 

exemptions. 

III. Limitations on Exemptions 

FDA has determined that premarket 

notification is not necessary to provide 

a reasonable assurance of safety and 

effectiveness for certain class II clinical 

electronic thermometers subject to the 

limitations outlined in table 1. This 

determination is based, in part, on the 

Agency’s knowledge of the device, 

including past experience and relevant 

reports or studies on device 

performance (as appropriate), the 

applicability of general and special 

controls, and the Agency’s ability to 

limit an exemption. 

A. General Limitations of Exemptions 

FDA’s proposal to grant an exemption 

from premarket notification applies only 

to those devices that have existing or 

reasonably foreseeable characteristics of 

commercially distributed devices within 

that generic type. After comment and 

issuance of a notice announcing FDA’s 

final determination, a manufacturer of a 

clinical electronic thermometer would 

still be required to submit a premarket 

notification to FDA before introducing a 

device or delivering it for introduction 

into commercial distribution when the 

device meets any of the conditions 

described in § 880.9 (21 CFR 880.9). 

B. Partial Limitations of Exemptions 

In addition to the general limitations, 

FDA may also partially limit an 

exemption from premarket notification 

requirements to specific devices within 

a listed device type when the initial 

Agency assessment determines that the 

factors laid out in the Class II 510(k) 

Exemption Guidance (Ref. 1) do not 

weigh in favor of exemption for all 

devices within a generic type of device. 

In such situations where a partial 

limitation of the exemption has been 

identified, FDA has determined that 

premarket notification is necessary to 

provide a reasonable assurance of safety 

and effectiveness for devices that fall 

outside of the limitations. In table 1, for 

example, FDA is listing the proposed 

exemption of clinical electronic 

thermometers but limits the exemption 


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75604 Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Notices 

to devices that are appropriately tested 

in accordance with specific FDArecognized standards (as outlined in the 

limitations) and excludes clinical 

electronic thermometers with 

telethermographic and continuous 

temperature measurement functions. 

Most contact and non-contact clinical 

electronic thermometers that are 

appropriately tested in accordance with 

specific FDA-recognized standards are 

well-understood devices; however, FDA 

considers premarket notification 

requirements for clinical thermometers 

with telethermographic and continuous 

temperature measurement functions to 

be necessary to provide a reasonable 

assurance of safety and effectiveness 

because such thermometers include 

newer technology that may require 

additional testing beyond that specified 

in FDA-recognized standards and have 

additional biocompatibility, 

interoperability, electromagnetic 

compatibility, electrical safety, and 

sterility considerations compared to 

clinical electronic thermometers 

without these types of functions. 

IV. Class II Device 

FDA is identifying the following class 

II device that, if finalized, would no 

longer require premarket notification 

under section 510(k) of the FD&C Act, 

subject to the general limitations to the 

exemptions found in § 880.9: 

TABLE 1—CLASS II DEVICES

21 CFR 

section Device description Product code Partial exemption limitation 

880.2910 ...... Clinical electronic thermometer .......... FLL ......... Exemption is limited to the following: 

1. Device is not a clinical thermometer with telethermography functions; 

2. Device is not a clinical thermometer with continuous temperature measurement functions; and 

3. Appropriate analysis and testing (such as outlined in the currently FDArecognized editions of ISO 80601–2–56 Medical electrical equipment— 

Part 2–56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement, or 

ASTM E1965 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature, or ASTM E1112 Standard 

Specification for Electronic Thermometer for Intermittent Determination of 

Patient Temperature, or ASTM E1104 Standard Specification for Clinical 

Thermometer Probe Covers and Sheaths) must validate specifications 

and performance of the device. 

FDA will assign new product codes to 

clinical electronic thermometers with 

telethermography functions and those 

with continuous temperature 

measurement functions in order to 

ensure that these devices can be 

identified distinctly from devices that 

will be exempt subject to the partial 

limitations under the existing product 

code (i.e., exempt and non-exempt 

devices within a device type will have 

different product codes). 

V. Reference 

The following reference is on display 

in the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday; it 

is also available electronically at https:// 

www.regulations.gov. FDA has verified 

the website address, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. FDA Guidance, ‘‘Procedures for Class II 

Device Exemptions from Premarket 

Notification, Guidance for Industry and 

CDRH Staff,’’ February 19, 1998, available at 

https://www.fda.gov/media/72685/download. 

Dated: October 31, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–24290 Filed 11–2–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Standardized Work Plan 

Form for Use With Applications to the 

Bureau of Health Workforce Research 

and Training Grants and Cooperative 

Agreements OMB No. 0906–0049— 

Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than December 4, 

2023. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Standardized Work Plan (SWP) Form for 

Use with Applications to the Bureau of 

Health Workforce (BHW) Research and 

Training Grants and Cooperative 

Agreements OMB No. 0906–0049— 

Extension 

Abstract: HRSA’s BHW requires 

applicants for training and research 

grants and cooperative agreements to 

submit work plans via the SWP form. 


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