41418 Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices 

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. 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Policy Clarification 

and Premarket Notification [510(k)] 

Submissions for Ultrasonic Diathermy 

Devices—Draft Guidance for Industry 

and Food and Drug Administration 

Staff’’ to the Office of the Center 

Director, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Jismi Johnson, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1524, Silver Spring, 

MD 20993–0002, 301–796–6424. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Ultrasonic diathermy devices are class 

II medical devices regulated under 21 

CFR 890.5300(a), Ultrasonic diathermy. 

Ultrasonic therapy devices must also 

comply with FDA radiation safety 

performance standards in 21 CFR part 

1010, Performance standards for 

electronic products: General, and 21 

CFR 1050.10, Ultrasonic therapy 

products. FDA recognizes that there are 

several IEC standards with which other 

countries require conformance or 

recognize for ultrasonic therapy 

products. This means that 

manufacturers, who distribute these 

products in both the United States and 

other countries, might have to ensure 

conformance of their products to IEC 

standards and comply with FDA 

performance standards. This may cause 

manufacturers to duplicate their efforts. 

When final, this draft guidance will 

clarify FDA’s policy related to 

compliance with applicable 

performance standards and 

conformance to IEC consensus 

standards for ultrasonic diathermy 

devices. If firms provide a declaration of 

conformity with the relevant provisions 

of the current FDA recognized versions 

of the IEC 60601–2–5 and IEC 61689 

standards, FDA does not intend to 

consider whether firms comply with 

certain requirements of 21 CFR 1050.10. 

This draft guidance will also provide 

recommendations for information to 

provide in 510(k) submissions for 

ultrasonic diathermy devices. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on policy clarification and premarket 

notification (510(k)) submissions for 

ultrasonic diathermy devices. It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Policy Clarification and Premarket 

Notification [510(k)] Submissions for 

Ultrasonic Diathermy Devices—Draft 

Guidance for Industry and Food and 

Drug Administration’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 1500003 to identify 

the guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

The draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 807, 

subpart E have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485; the 

collections of information in 21 CFR 

part 820 have been approved under 

OMB control number 0910–0073; the 

collections of information in 21 CFR 

parts 1002 through 1050 are approved 

under OMB control number 0910–0025. 

Dated: August 28, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–18470 Filed 8–30–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2153] 

Use of Real-World Evidence To 

Support Regulatory Decision-Making 

for Medical Devices; Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the 

guidance entitled ‘‘Use of Real-World 

Evidence to Support Regulatory 

Decision-Making for Medical Devices.’’ 

FDA is issuing this guidance to clarify 

how we evaluate real-world data to 

determine whether it may be 

sufficiently relevant and reliable to 

generate the types of real-world 

evidence that can be used in FDA 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices 41419 

regulatory decision-making for medical 

devices. The guidance describes the 

circumstances when real-world 

evidence can be used, and the scientific 

criteria that must be fulfilled in order to 

have confidence in the data. Finally, the 

guidance describes some examples of 

actual uses of real-world evidence that 

have already led to FDA decisions. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on August 31, 2017. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2016–D–2153 for ‘‘Use of Real-World 

Evidence to Support Regulatory 

Decision-Making for Medical Devices; 

Guidance for Industry and Food and 

Drug Administration Staff.’’ Received 

comments 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 

office 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. 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Use of Real-World 

Evidence to Support Regulatory 

Decision-Making for Medical Devices’’ 

to the Office of the Center Director, 

Guidance and Policy Development, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002; or the Office of Communication, 

Outreach, and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Benjamin Eloff, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2254, Silver Spring, 

MD 20993–0002, 301–796–8528; and 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

To protect and promote public health, 

FDA needs to understand and evaluate 

the available evidence related to 

regulated products. For medical devices, 

available evidence is traditionally 

comprised of non-clinical and in some 

cases, clinical studies conducted and 

provided to FDA by the device 

manufacturer or sponsor. However, FDA 

recognizes that a wealth of data covering 

medical device experience exists and is 

routinely collected in the course of 

treatment and management of patients. 

Under certain circumstances, these realworld data (RWD) may constitute realworld evidence (RWE), or clinical 

evidence regarding the usage and 

potential benefits or risks of a medical 

product derived from analysis of RWD, 

that may be of sufficient quality to help 

inform or augment FDA’s understanding 

of the benefit-risk profile of devices at 

various points in their life cycle, and 

could potentially be used to aid FDA in 

regulatory decision-making. 

This document describes the 

characteristics and sources of RWD and 

characteristics of RWE that may be 

sufficient for use in making various 

regulatory decisions. Because of its 

nature, the quality (i.e., relevance and 

reliability) of RWD can vary greatly 

across sources. Likewise, there are many 

types of regulatory decisions with 

varying levels of evidentiary needs. 

FDA’s evidentiary standards for 

regulatory decision-making are not 

changing. FDA encourages the use of 

RWE where appropriate, and will 

evaluate whether the available RWE is 


sradovich on DSK3GMQ082PROD with NOTICES
41420 Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices 

of sufficient relevance and reliability to 

address the specific regulatory decision 

being considered. 

This guidance does not affect any 

Federal, State or local laws or 

regulations or foreign laws or 

regulations that may otherwise be 

applicable to the use or collection of 

RWE and that provide protections for 

human subjects or patient privacy. This 

guidance should be used to 

complement, but not supersede, other 

device-specific and good clinical 

practice guidance documents. FDA 

considered comments received on the 

draft guidance that published in the 

Federal Register of July 27, 2016 (81 FR 

49228). FDA revised the guidance as 

appropriate in response to the 

comments. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on use of real-world 

evidence to support regulatory decisionmaking for medical devices. It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at https://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm or 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Use of Real-World Evidence to 

Support Regulatory Decision-Making for 

Medical Devices’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 1500012 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations and guidance. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 807, 

subpart E, have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 814, subparts A through E 

(premarket approval), have been 

approved under OMB control number 

0910–0231; the collections of 

information in 21 CFR part 814, subpart 

H (humanitarian device exemption), 

have been approved under OMB control 

number 0910–0332; the collections of 

information in 21 CFR part 812 

(investigational device exemption) have 

been approved under OMB control 

number 0910–0078; the collections of 

information in 21 CFR part 822 

(postmarket surveillance) have been 

approved under OMB control number 

0910–0449; the collections of 

information in 21 CFR 50.23 (exception 

from general requirements for informed 

consent) have been approved under 

OMB control number 0910–0586; the 

collections of information in 21 CFR 

part 54 (financial disclosure by clinical 

investigators) have been approved under 

OMB control number 0910–0396; the 

collections of information in 21 CFR 

56.115 (institutional review boards 

records) have been approved under 

OMB control number 0910–0130; and 

the collections of information in 21 CFR 

parts 50 subpart B (informed consent of 

human subjects) and 56 (institutional 

review boards) have been approved 

under OMB control number 0910–0755. 

The collections of information in the 

guidance ‘‘Requests for Feedback on 

Medical Device Submissions: The PreSubmission Program and Meetings with 

Food and Drug Administration Staff’’ 

have been approved under OMB control 

number 0910–0756. 

Dated: August 25, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–18469 Filed 8–30–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Peer Review of Draft NTP Approach to 

Genomic Dose-Response Modeling; 

Availability of Documents; Request for 

Comments; Notice of Expert Panel 

Meeting 

SUMMARY: The National Toxicology 

Program (NTP) announces an expert 

panel meeting and is obtaining 

comment on a proposed approach to 

genomic dose-response modeling. Prior 

to the expert panel meeting, NTP will 

host four webinars that present other 

approaches to genomic dose-response 

modeling. The expert panel meeting and 

four webinar presentations leading up to 

the meeting are open to the public. 

Registration is requested for both inperson meeting attendance and oral 

comment; registration is required to 

access the meeting webcast. URLs for 

live and archived pre-meeting webinars 

will be available at https://

ntp.niehs.nih.gov/about/org/ 

ntpexpertpanel/. 

DATES: 

Pre-Meeting Webinars: Dates are 

posted on the meeting Web site (https:// 

ntp.niehs.nih.gov/about/org/ 

ntpexpertpanel/). Registration is not 

required to view the pre-meeting 

webinars. 

Meeting: October 23–25, 2017; expert 

panel meeting begins at 8:30 a.m. 

Eastern Daylight Time (EDT) each day 

and continues until adjournment. 

Document Availability: Draft 

document should be available by 

August 23, 2017, at https://

ntp.niehs.nih.gov/about/org/ 

ntpexpertpanel/. 

Written Public Comment 

Submissions: Deadline is October 13, 

2017. 

Registration for Oral Comments: 

Deadline is October 13, 2017. 

Registration for Meeting and/or to 

View Webcast: Deadline is October 25, 

2017. Registration to view the meeting 

via webcast is required. 

ADDRESSES: 

Meeting Location: Rodbell 

Auditorium, Rall Building, NIEHS, 111 

T.W. Alexander Drive, Research 

Triangle Park, NC 27709. 

Meeting Web site: The draft 

document, preliminary agenda, 

registration, pre-meeting webinars 

details, and other meeting materials will 

be available at https://ntp.niehs.nih.gov/ 

about/org/ntpexpertpanel/. 

Webcast: The URL for viewing the 

expert panel meeting webcast will be 

provided to those who register. 

FOR FURTHER INFORMATION CONTACT: 

Anna Stamatogiannakis, ICF, 2635 

Meridian Parkway, Suite 200, Durham, 

NC, USA 27713. Phone: (919) 293–1652, 

Fax: (919) 293–1645, Email: 

anna.stamatogiannakis@icf.com. 

SUPPLEMENTARY INFORMATION: 

Background: NTP proposes to use the 

approach embodied in the BMDExpress 

software to perform gene and pathwaylevel genomic dose-response modeling 

as part of Tox21 Phase 3 and in vivo 

screening level studies. NTP seeks 

external scientific input on its proposed 

approach by an expert panel. NTP’s goal 


sradovich on DSK3GMQ082PROD with NOTICES