Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51633 

information originally supplied by the 

Federal government to the recipient for 

the purpose of disclosure to the public’’ 

(5 CFR 1320.3(c)(2)). 

III. Electronic Access 

Persons with access to the internet 

may obtain the document at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: November 2, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24192 Filed 11–6–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–1129] 

Medical Devices; Exemptions From 

Premarket Notification: Class II 

Devices; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing its intent to exempt a list of 

class II devices from premarket 

notification requirements, subject to 

certain limitations. The Agency has 

determined that, based on established 

factors, these devices no longer require 

premarket notification to provide 

reasonable assurance of safety and 

effectiveness. FDA is publishing this 

notice to obtain comments regarding the 

proposed exemptions, in accordance 

with the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act). 

DATES: Submit either electronic or 

written comments on the notice by 

January 8, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before January 8, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of January 8, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is 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– 

2017–N–1129 for ‘‘Medical Devices; 

Exemptions from Premarket 

Notification: Class II Devices; 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. 

• 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.gpo.gov/ 

fdsys/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. 

FOR FURTHER INFORMATION CONTACT: 

Bryce Bennett, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5244, Silver Spring, 

MD 20993, 301–348–1446, 

Gregory.Bennett@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION : 

I. Statutory Background 

Section 510(k) of the FD&C Act (21 

U.S.C. 360(k)) and the implementing 

regulations, 21 CFR part 807 subpart E, 

require persons who intend to market a 

new device to submit and obtain 

clearance of 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, 


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51634 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 

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 required to be published under 

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

FDA published this notice in the 

Federal Register of March 14, 2017 (82 

FR 13609). Under section 510(m)(1)(B) 

of the FD&C Act, FDA must publish in 

the Federal Register, within 210 days of 

enactment of the Cures Act, a list 

representing its final determination 

regarding the exemption of the devices 

that were contained in the list published 

under section 510(m)(1)(A). FDA 

published that list in the Federal 

Register of July 11, 2017 (82 FR 31976). 

As amended, section 510(m)(2) of the 

FD&C Act provides that, 1 day after the 

date of publication of the final list under 

section 510(m)(1), FDA may exempt a 

class II device from the requirement to 

submit a report under section 510(k) of 

the FD&C Act upon its own initiative or 

a petition of an interested person, if 

FDA determines that a report under 

section 510(k) is not necessary to assure 

the safety and effectiveness of the 

device. To do so, FDA must publish in 

the Federal Register a notice of its 

intent to exempt the device, or of the 

petition, and provide a 60-day period 

for public comment. Within 120 days 

after the issuance of this notice, FDA 

must publish an order in the Federal 

Register that sets forth its final 

determination regarding the exemption 

of the device that was the subject of the 

notice. If FDA fails to respond to a 

petition under section 510(m)(2) of the 

FD&C Act within 180 days of receiving 

it, the petition shall be deemed granted. 

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 assure 

the safety and effectiveness of the class 

II devices listed 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 for class II 

devices listed in table 1 applies only to 

those devices that have existing or 

reasonably foreseeable characteristics of 

commercially distributed devices within 

that generic type, or, in the case of in 

vitro diagnostic devices, for which a 

misdiagnosis, as a result of using the 

device, would not be associated with 

high morbidity or mortality. FDA 

proposes that a manufacturer of a listed 

device 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 21 CFR 

862.9 to 21 CFR 892.9. 

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 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 in a 

particular group. In such situations 

where a partial exemption limitation 

has been identified, FDA has 

determined that premarket notification 

is necessary to provide a reasonable 

assurance of safety and effectiveness for 

these devices. In table 1, for example, 

FDA is listing the proposed exemption 

of the genetic health risk assessment 

system, but limits the exemption to such 

devices that have received a first-time 

FDA marketing authorization (e.g., 

510(k) clearance) for the genetic health 

risk assessment system (a ‘‘one-time 

FDA reviewed genetic health risk 

assessment system’’). FDA believes that 

a one-time FDA review (e.g., premarket 

notification) of a genetic health risk 

assessment system is necessary to 

provide reasonable assurance of the 

safety and effectiveness of the device. 

FDA believes that a one-time FDA 

review of a genetic health risk 

assessment system is necessary to 

mitigate the risk of false negatives and 

false positives by ensuring that certain 

information be submitted to FDA to 

allow the Agency to assess the safety 

and effectiveness of the devices and the 

regulatory controls necessary to address 

those issues as well as to ensure the 

devices perform to acceptable standards. 

IV. List of Class II Devices 

FDA is identifying the following list 

of class II devices 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 

§§ 862.9 to 892.9: 

TABLE 1—CLASS II DEVICES

21 CFR section Device type Product 

code 

Partial exemption limitation 

(if applicable) 

862.1840 ............... Total 25-hydroxyvitamin D Mass Spectrometry Test 

System.

PSL 


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Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51635 

TABLE 1—CLASS II DEVICES—Continued 

21 CFR section Device type Product 

code 

Partial exemption limitation 

(if applicable) 

866.5950 ............... Genetic Health Risk Assessment System .................... PTA Exemption is limited to a genetic health risk assessment system that has received a first-time FDA marketing authorization (e.g., 510(k) clearance) for the 

genetic health risk assessment system (a ‘‘one-time 

FDA reviewed genetic health risk assessment system’’). 

876.1500 ............... Endoscopic Maintenance System ................................. PUP 

880.6710 ............... Purifier, Water, Ultraviolet, Medical ............................... KMG 

884.5960 ............... Vibrator for Therapeutic Use, Genital ........................... KXQ 

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 Web site address, as of the date this 

document publishes in the Federal 

Register, but Web sites 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/ 

downloads/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/UCM080199.pdf. 

Dated: October 31, 2017. 

Lauren Silvis, 

Chief of Staff. 

[FR Doc. 2017–24163 Filed 11–6–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2013–N–0618; FDA– 

2013–N–1155; FDA–2010–N–0118; FDA– 

2011–N–0655; FDA–2014–N–0086; FDA– 

2011–N–0144; FDA–2016–N–2836] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at https://www.reginfo.gov/public/do/ 

PRAMain. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB control 

No. 

Date approval 

expires 

Reporting and Recordkeeping for Electronic Products—General Requirements ................................................... 0910–0025 7/31/2020 

Food Labeling Regulations ...................................................................................................................................... 0910–0381 7/31/2020 

Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response 

Act of 2002 ........................................................................................................................................................... 0910–0520 7/31/2020 

Animal Generic Drug User Fee Act Cover Sheet ................................................................................................... 0910–0632 7/31/2020 

Potential Tobacco Product Violations Reporting Form ........................................................................................... 0910–0716 7/31/2020 

Voluntary Qualified Importer Program Guidance for Industry ................................................................................. 0910–0840 7/31/2020 

Donor Risk Assessment Questionnaire for the FDA/National Heart, Lung, and Blood Institute—Sponsored 

Transfusion-Transmissible Infectious Monitoring System ................................................................................... 0910–0841 7/31/2020 

Dated: November 2, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24189 Filed 11–6–17; 8:45 am] 

BILLING CODE 4164–01–P 


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