Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices 41417 

implements the electronic submission 

requirements of section 745A(a) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379k–1(a)) for study data 

contained in NDAs, ANDAs, BLAs, and 

INDs to CBER or CDER by specifying the 

format for electronic submissions. This 

provision required that the electronic 

format for submission of applications be 

specified in guidance and effective no 

sooner than 24 months after issuance of 

the final guidance. The initial timetable 

for the implementation of electronic 

submission requirements for study data 

is December 17, 2016 (24 months after 

issuance of final guidance for NDAs, 

BLAs, ANDAs, and 36 months for INDs). 

The eStudy Data guidance states that a 

Federal Register notice will specify the 

transition date for all version updates 

(with the month and day for the 

transition date corresponding to March 

15). 

FDA currently supports and requires 

MedDRA for the coding of adverse 

events in studies submitted to FDA’s 

CBER or CDER in NDAs, ANDAs, BLAs, 

and INDs in the electronic common 

technical document (eCTD) format. 

However, the requirement to code 

adverse events using MedDRA in the 

most current version (available at 

https://www.meddra.org) does not apply 

to postmarketing studies that are 

submitted in eCTD sections 5.3.5.4 and 

5.3.6 (https://www.fda.gov/downloads/ 

Drugs/DevelopmentApprovalProcess/ 

FormsSubmissionRequirements/ 

ElectronicSubmissions/ 

UCM163175.pdf). 

Generally, the studies included in a 

submission are conducted over many 

years and may have used different 

MedDRA versions to code adverse 

events. The expectation is that sponsors 

or applicants will use the most current 

version of MedDRA at the time of study 

start. However, there is no requirement 

to recode earlier studies. The transition 

date for support and requirement to use 

the most current version of MedDRA is 

March 15, 2018. Although the use of the 

most current version is supported as of 

this Federal Register notice and 

sponsors or applicants are encouraged 

to begin using it, the use of the most 

current version will only be required in 

submissions for studies that start after 

March 15, 2019. The Catalog will list 

March 15, 2019, as the ‘‘date 

requirement begins.’’ The Study Data 

Technical Conformance Guide provides 

additional information and 

recommendations on the coding of 

adverse events (https://www.fda.gov/ 

downloads/forindustry/datastandards/ 

studydatastandards/ucm384744.pdf). 

FDA will no longer support version 8 

or earlier of MedDRA. FDA support for 

earlier versions of MedDRA will end for 

studies that start after March 15, 2019. 

The FDA Data Standards Catalog will be 

updated to list March 15, 2019, as the 

‘‘date support ends.’’ Studies that start 

after March 15, 2019, will be required to 

use the most current version of 

MedDRA. 

Dated: August 28, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–18471 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–2017–D–4764] 

Policy Clarification and Premarket 

Notification (510(k)) Submissions for 

Ultrasonic Diathermy Devices; Draft 

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 draft 

guidance entitled ‘‘Policy Clarification 

and Premarket Notification [510(k)] 

Submissions for Ultrasonic Diathermy 

Devices—Draft Guidance for Industry 

and Food and Drug Administration 

Staff.’’ When final, this draft guidance 

will clarify FDA’s policy related to 

compliance with applicable 

performance standards and 

conformance to International 

Electrotechnical Commission (IEC) 

consensus standards for ultrasonic 

diathermy devices. This draft guidance 

will also provide recommendations for 

information to provide in 510(k) 

submissions for ultrasonic diathermy 

devices. This draft guidance is not final 

nor is it in effect at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment of this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by October 30, 

2017. 

ADDRESSES: You may submit comments 

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– 

2017–D–4764 for ‘‘Policy Clarification 

and Premarket Notification [510(k)] 

Submissions for Ultrasonic Diathermy 

Devices—Draft Guidance for Industry 

and Food and Drug Administration.’’ 

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 


sradovich on DSK3GMQ082PROD with NOTICES
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