45854 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

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 ‘‘Display Devices for 

Diagnostic Radiology’’ 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: 

Robert Ochs, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4308, Silver Spring, 

MD 20993–0002, 301–796–6661. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This guidance applies to display 

devices intended for diagnostic 

radiology as identified in Section III of 

the guidance and currently classified 

under 21 CFR 892.2050 as class II 

devices according to section 513(a)(1) of 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) (21 U.S.C. 

360c(a)(1)) with the assigned product 

code PGY. This guidance is intended to 

assist industry in preparing a 510(k) for 

display devices intended for use in 

diagnostic radiology. This guidance 

provides recommendations for the types 

of information you should provide in 

your 510(k) submission for display 

devices intended for diagnostic 

radiology. This information 

supplements the requirements for a 

510(k) submission found in 21 CFR 807 

Subpart E, as well as recommendations 

provided in other FDA guidance 

documents concerning the specific 

content of a 510(k) submission. 

FDA considered comments on the 

draft guidance that appeared in the 

Federal Register of February 9, 2016 (81 

FR 6869). FDA revised the guidance as 

appropriate in response to the 

comments. 

This guidance applies to workstation 

medical image displays for diagnostic 

radiology. These devices are classified 

as class II devices that are intended to 

be used in controlled viewing 

conditions to display and view digital 

images for primary image interpretation. 

Display devices for diagnostic radiology 

may also be referred to as soft-copy 

displays or medical grade monitors. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents the current 

thinking of FDA on Display Devices for 

Diagnostic Radiology. 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.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Display Devices for Diagnostic 

Radiology’’ may send an email request 

to CDRH-Guidance@fda.hhs.gov to 

receive an electronic copy of the 

document. Please use the document 

number 1500022 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. 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; and the collections 

of information in the guidance entitled 

‘‘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: September 25, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–21078 Filed 9–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5372] 

Marketing Clearance of Diagnostic 

Ultrasound Systems and Transducers; 

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 ‘‘Marketing Clearance 

of Diagnostic Ultrasound Systems and 

Transducers; Draft Guidance for 

Industry and Food and Drug 

Administration Staff.’’ This draft 

guidance provides detailed information 

recommended for manufacturers 

seeking marketing clearance of 

diagnostic ultrasound systems and 

transducers. This draft guidance is not 

final nor is it in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by January 2, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45855 

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–5372 for ‘‘Marketing Clearance 

of Diagnostic Ultrasound Systems and 

Transducers; Draft 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 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

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 ‘‘Marketing 

Clearance of Diagnostic Ultrasound 

Systems and Transducers; 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: 

Shahram Vaezy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4227A, Silver 

Spring, MD 20993–0002, 301–796–6242 

or Keith Wear, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 62, Rm. 2104, Silver Spring, 

MD 20993–0002, 301–796–2538. 

SUPPLEMENTARY INFORMATION: 

I. Background 

When finalized, this draft guidance 

will provide detailed recommendations 

for manufacturers seeking marketing 

clearance of diagnostic ultrasound 

systems and transducers. In addition, 

this draft guidance, when final, is 

intended to supersede FDA’s 2008 

guidance entitled, ‘‘Information for 

Manufacturers Seeking Marketing 

Clearance of Diagnostic Ultrasound 

Systems and Transducers,’’ regarding 

FDA’s approach to the regulation of 

certain diagnostic ultrasound devices. 

(Ref. 1). In addition to the regulatory 

approaches outlined in the 2008 

document, additional guidance is 

provided for deciding when a device 

modification to a diagnostic ultrasound 

device can be made without the need for 

submission of a new premarket 

notification (510(k)) submission. As 

before, device sponsors who comply 

with the applicable premarket 

notification requirements will continue 

to be exempt from the Electronic 

Product Radiation Control reporting 

requirements in 21 CFR 1002.12, for 

diagnostic ultrasound devices, as 

described in the notice to industry 

entitled ‘‘Exemption from Reporting 

under 21 CFR 1002’’ (dated February 24, 

1986) (Ref. 2). When finalized, this draft 

guidance is applicable to diagnostic 

ultrasound devices under 21 CFR 

892.1550 (Ultrasonic pulsed doppler 

imaging system), 21 CFR 892.1560 

(Ultrasonic pulsed echo imaging 

system), and 21 CFR 892.1570 

(Diagnostic ultrasonic transducer). 

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 ‘‘Diagnostic Ultrasound Systems and 

Transducer 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 https://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 ‘‘Marketing Clearance of Diagnostic 

Ultrasound Systems and Transducers; 

Draft Guidance for Industry and Food 

and Drug Administration Staff’’ may 

send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 560 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 


sradovich on DSK3GMQ082PROD with NOTICES
45856 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 

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 820 have been approved under 

OMB control number 0910–0073, and 

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 

parts 1002 and 1010 are approved under 

OMB control number 0910–0025. 

V. References 

The following references are on 

display in the Dockets Management 

Staff (see ADDRESSES) and are available 

for viewing by interested persons 

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

through Friday; they are 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, ‘‘Information for 

Manufacturers Seeking Marketing Clearance 

of Diagnostic Ultrasound Systems and 

Transducers.’’ Available at: https://

www.fda.gov/downloads/UCM070911.pdf. 

2. FDA, ‘‘Information for Industry.’’ 

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

RadiationEmittingProducts/Radiation

EmittingProductsandProcedures/Medical

Imaging/ucm115357.htm 

Dated: September 22, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–21077 Filed 9–29–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5776] 

Equivalence of Complex Products; 

Public Workshop; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘Demonstrating 

Equivalence of Generic Complex Drug 

Substances and Formulations: Advances 

in Characterization and In Vitro 

Testing.’’ The purpose of the workshop 

is to share FDA’s current experiences on 

the evaluation and characterization of 

critical quality attributes for complex 

drug substances (e.g. polymeric and 

naturally derived substances and 

peptides) and formulations (e.g. 

liposomes, emulsions, suspensions, and 

polymeric inserts); discuss current and 

future innovative approaches for the 

development and regulatory review of 

equivalent complex drug products; 

obtain input from various stakeholders 

on how to conduct and assess critical 

quality attribute measurements to 

demonstrate equivalence of complex 

drug products; and request comments 

on these topics. 

DATES: The public workshop will be 

held on October 6, 2017, from 8:30 a.m. 

to 4:30 p.m. Submit either electronic or 

written comments on this public 

workshop by November 10, 2017. See 

the SUPPLEMENTARY INFORMATION section 

for registration date and information. 

ADDRESSES: The public workshop will 

be held at FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503 B+C), Silver Spring, MD 20993– 

0002. Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/Working

atFDA/BuildingsandFacilities/WhiteOak

CampusInformation/ucm241740.htm. 

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 November 10, 2017. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of November 10, 2017. 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–5776 for ‘‘Demonstrating 

Equivalence of Generic Complex Drug 

Substances and Formulations: Advances 

in Characterization and In Vitro 

Testing.’’ 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 


sradovich on DSK3GMQ082PROD with NOTICES