Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 50145 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Sergio de del Castillo, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 1538, 

Silver Spring, MD 20993–0002, 301– 

796–6419; 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, 

301–240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The automatic class III designation for 

devices of a new type occurs by 

operation of law and without any action 

by FDA, regardless of the level of risk 

posed. Any device that is of a new type 

that was not in commercial distribution 

before May 28, 1976, is automatically 

classified as, and remains within, class 

III and requires premarket approval 

unless and until FDA takes an action to 

classify or reclassify the device section 

513(f)(1) of the FD&C Act (21 U.S.C. 

360c(f)(1)). We refer to these devices as 

‘‘postamendments devices’’ because 

they were not in commercial 

distribution prior to the date of 

enactment of the Medical Device 

Amendments of 1976. 

FDA may classify a device through 

the De Novo classification process, 

which is the pathway authorized under 

section 513(f)(2) of the FD&C Act (21 

U.S.C. 360c(f)(2)). A person may submit 

a De Novo request after submitting a 

premarket notification under section 

510(k) of the FD&C Act and receiving a 

not substantially equivalent (NSE) 

determination (section 513(f)(2)(A)(i) of 

the FD&C Act). A person may also 

submit a De Novo request without first 

submitting a premarket notification 

under section 510(k), if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence (section 513(f)(2)(A)(ii) of 

the FD&C Act). 

Upon receipt of a De Novo request, 

FDA is required to classify the device by 

written order (section 513(f)(2)(A)(iii) of 

the FD&C Act). The classification will 

be according to the criteria under 

section 513(a)(1) of the FD&C Act (21 

U.S.C. 360c(a)(1)). Per section 

513(f)(2)(B)(i) of the FD&C Act, the 

classification is the initial classification 

of the device for the purposes of section 

513(f)(1) of the FD&C Act. 

We believe De Novo classification 

will enhance patients’ access to 

beneficial innovation, in part by 

reducing regulatory burdens. When FDA 

classifies a device into class I or II via 

the De Novo classification process, the 

device can serve as a predicate for 

future devices of that type, including for 

510(k)s (section 513(f)(2)(B)(i)). As a 

result, other device sponsors do not 

have to submit a De Novo request or 

PMA in order to market a substantially 

equivalent device (see 21 U.S.C. 360c(i), 

defining ‘‘substantial equivalence’’). 

Instead, sponsors can use the lessburdensome 510(k) process, when 

applicable, as a pathway to market their 

device. 

FDA is issuing this document to 

provide guidance on the process for the 

submission and review of a De Novo 

request under section 513(f)(2) of the 

FD&C Act, also known as the De Novo 

classification process. This guidance 

also provides updated recommendations 

for interactions with FDA related to the 

De Novo classification process, 

including what information to submit 

when seeking a path to market via the 

De Novo classification process. This 

guidance will provide clarity regarding 

the Agency’s review process and 

expectations for information to be 

submitted in a De Novo request and 

ensures predictability and consistency 

for sponsors. 

FDA considered comments received 

on the draft guidance that appeared in 

the Federal Register (79 FR 47651) of 

August 14, 2014. FDA revised the 

guidance as appropriate in response to 

the comments. This document 

supersedes ‘‘New Section 513(f)(2)— 

Evaluation of Automatic Class III 

Designation, Guidance for Industry and 

CDRH Staff’’ dated February 19, 1998. 

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 the De Novo 

Classification Process (Evaluation of 

Automatic Class III Designation). 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 ‘‘De Novo Classification Process 

(Evaluation of Automatic Class III 

Designation)’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 1760 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 

the guidance ‘‘De Novo Classification 

Process (Evaluation of Automatic Class 

III Designation)’’ have been approved 

under OMB control number 0910–0844. 

The collections of information in the 

guidance document ‘‘Requests for 

Feedback on Medical Device 

Submissions: The Pre-Submission 

Program and Meetings with Food and 

Drug Administration Staff’’ have been 

approved under OMB control number 

0910–0756. 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 have been approved under 

OMB control number 0910–0231; and 

the collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485. 

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23492 Filed 10–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5975] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Survey of Alumni 

Commissioner’s Fellowship Program 

Fellows 

AGENCY: Food and Drug Administration, 

HHS. 


sradovich on DSK3GMQ082PROD with NOTICES
50146 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the Survey of 

Alumni Commissioner’s Fellowship 

Program Fellows. 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 29, 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 December 29, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 29, 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–5975 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Survey of 

Alumni Commissioner’s Fellowship 

Program Fellows.’’ 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: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Survey of Alumni Commissioner’s 

Fellowship Program Fellows—OMB 

Control Number 0910—NEW 

FDA is requesting approval from OMB 

to gather information from Alumni 

Commissioner’s Fellowship Program 

(CFP) Fellows. The information from 

Alumni CFP Fellows will allow FDA’s 

Office of the Commissioner (OC) to 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 50147 

easily and efficiently elicit and review 

program feedback. The online voluntary 

survey will assist the Agency in 

promoting and protecting the public 

health by encouraging outside persons 

to share their experience with the FDA 

while a Commissioner’s Fellow. The 

process will reduce the time and cost of 

submitting written documentation to the 

Agency and lessen the likelihood of 

surveys being misrouted within the 

Agency mail system. The information 

gathered by the survey will be used to 

gain insights into, and to document, 

impacts that the CFP has had and is 

having on former CFP fellows and 

contributions and impacts that the 

former fellows are making in their 

current work. The voluntary surveys 

include questions to assess the 

following measures: Post-fellowship 

employment (e.g., employment type); 

number of awards; number of 

contributions while a CFP fellow (e.g., 

number of publications, guidance 

documents authored or co-authored); 

and contributions in their field (e.g., list 

of publications). 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Fellowship Program Survey ................................................. 35 1 35 * 0.50 17.5 

1There are no capital costs or operating maintenance costs associated with this collection of information. 

* 30 minutes. 

FDA based these estimates on the 

number of fellows who have graduated 

and left the Agency over the past 5 

years. 

Dated: October 24, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23515 Filed 10–27–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4180] 

Voluntary Medical Device 

Manufacturing and Product Quality 

Program; Public Workshop; Request 

for Comments; Reopening of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

reopening the comment period provided 

in the notice entitled ‘‘Voluntary 

Medical Device Manufacturing and 

Product Quality Program; Public 

Workshop; Request for Comments,’’ 

published in the Federal Register of 

July 25, 2017 (82 FR 34531). That notice 

announced the public workshop to be 

held on October 10, 2017, and requested 

comments by October 18, 2017. The 

Agency is taking this action to allow 

interested parties additional time to 

submit comments. 

DATES: FDA is reopening the comment 

period for the public workshop 

‘‘Voluntary Medical Device 

Manufacturing and Product Quality 

Program; Public Workshop; Request for 

Comments’’ published on July 25, 2017 

(82 FR 34531). Submit either electronic 

or written comments on this public 

workshop by December 14, 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 December 14, 

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

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of December 14, 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–4180 for ‘‘Voluntary Medical 

Device Manufacturing and Product 

Quality Program; Public Workshop; 

Request for Comments; Reopening 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 


sradovich on DSK3GMQ082PROD with NOTICES