50144 Federal Register / Vol. 82, No. 208 / Monday, October 30, 2017 / Notices 

3520). The guidance refers to collections 

of information for filling out and 

submitting Form FDA 3913 (User Fee 

Payment Refund Request), previously 

approved under OMB control number 

0910–0805, and Form FDA 3914 (User 

Fee Payment Transfer Request), 

previously approved under OMB 

control number 0910–0805. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: October 25, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23526 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–2011–D–0689] 

De Novo Classification Process 

(Evaluation of Automatic Class III 

Designation); 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 ‘‘De Novo 

Classification Process (Evaluation of 

Automatic Class III Designation).’’ The 

purpose of this document is to provide 

guidance on the process for the 

submission and review of a De Novo 

classification request (hereafter a ‘‘De 

Novo request’’) under the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act), 

also known as the De Novo 

classification process. FDA is issuing 

this guidance to also provide 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 

replaces ‘‘New Section 513(f)(2)— 

Evaluation of Automatic Class III 

Designation, Guidance for Industry and 

CDRH Staff,’’ dated February 19, 1998. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on October 30, 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–0689 for ‘‘De Novo 

Classification Process (Evaluation of 

Automatic Class III Designation); 

Guidance for Industry and Food and 

Drug Administration Staff; 

Availability.’’ 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 guidance 

document entitled ‘‘De Novo 

Classification Process (Evaluation of 

Automatic Class III Designation)’’ 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, 


sradovich on DSK3GMQ082PROD with NOTICES
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