Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49375 

and expedite the review of breakthrough 

technologies. 

The Breakthrough Devices Program 

also supersedes the Priority Review 

Program, which implemented statutory 

criteria for granting priority review to 

PMA submissions for medical devices, 

applied those criteria to other types of 

premarket submissions for medical 

devices, and included standard 

procedures to achieve an efficient 

priority review process. 

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This draft guidance is being issued 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The draft guidance, when finalized, will 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 ‘‘Breakthrough Devices Program; 

Draft Guidance for Industry and Food 

and Drug Administration Staff.’’ 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of the draft guidance may do so by 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.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm or 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Breakthrough Devices Program’’ may 

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

electronic copy of the document. Please 

use the document number 1833 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 for De Novo classification 

requests have been approved under 

OMB control number 0910–0844; the 

collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078; the 

collections of information in 21 CFR 

part 814, subparts A through E, have 

been approved under OMB control 

number 0910–0231; the collections of 

information in 21 CFR part 814, subpart 

H, have been approved under OMB 

control number 0910–0332; 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 

part 822 have been approved under 

OMB control number 0910–0449; and 

the collections of information regarding 

‘‘Requests for Feedback on Medical 

Device Submissions’’ have been 

approved under OMB control number 

0910–0756. 

Dated: October 20, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–23195 Filed 10–24–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0453] 

Deciding When To Submit a 510(k) for 

a Change to an Existing Device; 

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 ‘‘Deciding When to 

Submit a 510(k) for a Change to an 

Existing Device.’’ FDA is issuing this 

final guidance document to clarify when 

a change in a legally marketed medical 

device would require that a 

manufacturer submit a premarket 

notification (510(k)) to FDA. This 

guidance document supersedes 

‘‘Deciding When to Submit a 510(k) for 

a Change to an Existing Device,’’ issued 

January 10, 1997. FDA is correcting an 

error in the docket number assigned to 

the ‘‘Deciding When to Submit a 510(k) 

for a Change to an Existing Device’’ 

notice of availability when it published 

in the Federal Register (81 FR 52443, 

August 8, 2016). The docket number 

currently is FDA–2016–D–2021. FDA is 

changing the docket number to FDA– 

2011–D–0453. This action is 

administrative in nature and is being 

taken to avoid any potential confusion 

in the docket. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 25, 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– 

2011–D–0453 for ‘‘Deciding When to 

Submit a 510(k) for a Change to an 

Existing Device.’’ 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. 


sradovich on DSK3GMQ082PROD with NOTICES
49376 Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 

• 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 guidance 

document entitled ‘‘Deciding When to 

Submit a 510(k) for a Change to an 

Existing Device ’’ 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: 

Rebecca Nipper, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1540, Silver Spring, 

MD 20993–0002, 301–796–6527; 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 

A 510(k) is required when a legally 

marketed device subject to 510(k) 

requirements is about to be significantly 

changed or modified in design, 

components, method of manufacture, or 

intended use. Significant changes or 

modifications are those that could 

significantly affect the safety or 

effectiveness of the device, or major 

changes or modifications in the 

intended use of the device 

(§ 807.81(a)(3) (21 CFR 807.81(a)(3)). 

This guidance will aid manufacturers of 

medical devices who intend to modify 

a 510(k)-cleared device or other device 

subject to 510(k) requirements, such as 

a preamendments device or a device 

that was granted marketing 

authorization via the De Novo 

classification process under section 

513(f)(2) of the Federal Food, Drug, and 

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

360c(f)(2)) (also referred to together as 

‘‘existing devices’’), during the process 

of deciding whether the modification 

exceeds the regulatory threshold of 

§ 807.81(a)(3) for submission and 

clearance of a new 510(k). 

This guidance supersedes the original 

‘‘Deciding When to Submit a 510(k) for 

a Change to an Existing Device,’’ issued 

on January 10, 1997. That guidance 

provided the Agency’s interpretation of 

whether the modification exceeds the 

regulatory threshold of § 807.81(a)(3), 

with principles and points for 

manufacturers to consider in analyzing 

how changes in devices may affect 

safety or effectiveness and determining 

whether a new 510(k) must be 

submitted for a particular type of 

change. This final guidance preserves 

the basic format and content of the 

original, with updates to add clarity. 

The added clarity is intended to 

increase consistent interpretations of the 

guidance by FDA staff and 

manufacturers. 

This guidance is not intended to 

implement significant policy changes to 

FDA’s current thinking on when 

submission of a new 510(k) is required 

for a change to an existing device. 

Rather, the intent of this guidance is to 

enhance the predictability, consistency, 

and transparency of the ‘‘when to 

submit’’ decision-making process by 

providing a least burdensome approach, 

and describing in greater detail the 

regulatory framework, policies, and 

practices underlying such a decision. 

The recommendations discussed in this 

guidance for evaluating when a change 

to an existing device would trigger the 

requirement that a manufacturer submit 

a new 510(k) to the Agency are 

consistent with least burdensome 

principles (Refs. 1 and 2). The least 

burdensome provision concerning 

510(k)s states that FDA ‘‘shall only 

request information that is necessary 

. . .’’ and ‘‘shall consider the least 

burdensome means of demonstrating 

substantial equivalence . . .’’ (see 

section 513(i)(1)(D)(i) of the FD&C Act). 

While not changing the standard for 

substantial equivalence, this provision 

states that FDA shall only request the 

‘‘minimum required information’’ 

necessary to support a determination of 

substantial equivalence (see sections 

513(i)(1)(D)(ii)–(iii) of the FD&C Act). 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of the guidance document 

entitled ‘‘Deciding When to Submit a 

510(k) for a Software Change to an 

Existing Device’’ to aid manufacturers of 

medical devices who intend to make 

software changes to an existing device 

during the process of deciding whether 

the software modification exceeds the 

regulatory threshold of § 807.81(a)(3) for 

submission and clearance of a new 

510(k). 

FDA considered comments received 

on the draft guidance that appeared in 

the Federal Register of August 8, 2016. 

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 ‘‘Deciding When to 

Submit a 510(k) for a Change to an 

Existing Device.’’ 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 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49377 

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 ‘‘Deciding When to Submit a 510(k) 

for a Change to an Existing Device’’ may 

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

electronic copy of the document. Please 

use the document number 1500054 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 820 are approved under 

OMB control number 0910–0073; the 

collections of information in 21 CFR 

part 807, subpart E are approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 803 have been approved under 

OMB control number 0910–0437; and 

the collections of information in 21 CFR 

parts 801 and 809 are approved under 

OMB control number 0910–0485. 

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 addresses, as of the date 

this document publishes in the Federal 

Register, but Web sites are subject to 

change over time. 

1. ‘‘The Least Burdensome Provisions of the 

FDA Modernization Act of 1997: 

Concept and Principles,’’ dated October 

4, 2002, available at: https://

www.fda.gov/downloads/Medical

Devices/DeviceRegulationandGuidance/ 

GuidanceDocuments/ucm085999.pdf. 

2. ‘‘Suggested Format for Developing and 

Responding to Deficiencies in 

Accordance with the Least Burdensome 

Provisions of FDAMA,’’ dated November 

2, 2000, available at: https://

www.fda.gov/downloads/Medical

Devices/DeviceRegulationandGuidance/ 

GuidanceDocuments/ucm073680.pdf. 

Dated: October 20, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–23197 Filed 10–24–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0655] 

Animal Generic Drug User Fee Act; 

Recommendations; Request for 

Comments; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability; request 

for comments; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of the 

Animal Generic Drug User Fee Act 

(AGDUFA) reauthorization draft 

recommendations and extending the 

comment period to allow interested 

persons 30 days to submit comments on 

these draft recommendations. 

DATES: FDA is extending the comment 

period on the AGDUFA reauthorization 

and draft recommendations. Submit 

either electronic or written comments 

on the draft recommendations by 

November 24, 2017. 

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 November 24, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 24, 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– 

2011–N–0655 for ‘‘Animal Generic Drug 

User Fee Act; Recommendations; 

Request for Comments; Extension of 

Comment Period’’ 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 


sradovich on DSK3GMQ082PROD with NOTICES