2710 Federal Register / Vol. 80, No. 12 / Tuesday, January 20, 2015 / Notices 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 35). 

Dated: January 9, 2015. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2015–00699 Filed 1–16–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0025] 

Medical Device Accessories: Defining 

Accessories and Classification 

Pathway for New Accessory Types; 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Medical Device Accessories: 

Defining Accessories and Classification 

Pathway for New Accessory Types.’’ 

This draft document provides proposed 

guidance to industry and FDA staff 

about the regulation of accessories in 

medical devices. The guidance explains 

what FDA considers to be an 

‘‘accessory,’’ outlines how the riskbased framework for the classification of 

devices applies to accessories, and 

describes the use of the de novo 

classification process for the 

classification of new types of 

accessories. This draft guidance is not 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on the draft guidance by April 20, 2015. 

Submit comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 by March 23, 

2015. See section IV of this document, 

the ‘‘Paperwork Reduction Act of 1995.’’ 

ADDRESSES: 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single hard copy of the draft guidance 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 ‘‘Medical Device 

Accessories: Defining Accessories and 

Classification Pathway for New 

Accessory Types’’ 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. 

Submit electronic comments on the 

draft guidance or the information 

collection to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Sugato De, Center for Devices and 

Radiological Health (CDRH), Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5435, 

Silver Spring, MD 20993–0002, 301– 

796–6270 or Stephen Ripley, Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 71, 

Rm. 7301, Silver Spring, MD 20993– 

0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance document is 

intended to provide guidance to 

industry and FDA staff about the 

regulation of accessories to other 

medical devices. In doing so, this 

guidance document explains what FDA 

considers to be an ‘‘accessory’’ and 

outlines how the risk-based framework 

for the classification of devices applies 

to accessories. In addition, this guidance 

describes use of the de novo 

classification process to classify new 

types of accessory devices under 

Section 513(f)(2) of the Federal Food, 

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

(21 U.S.C. 360c(f)(2)) based on risk and 

the ability of general and special 

controls to assure safety and 

effectiveness. 

For the purposes of this guidance 

document, FDA considers an 

‘‘accessory’’ as a medical device that is 

intended to support, supplement, and/

or augment the performance of one or 

more medical devices. In practice, the 

distinctions among devices that support, 

supplement, and/or augment parent 

devices are subtle and many devices 

that we would consider to be an 

accessory may do more than one of 

these things. Thus, if the device is 

intended to support, supplement, and/

or augment the performance of one or 

more parent devices, we intend to 

consider the device as an accessory. 

Once a specific article has been 

determined to be an accessory, the 

guidance document describes how the 

accessory is classified based on its risks 

when used as intended with the 

intended parent device(s). In practice, 

FDA may classify individual accessories 

either by inclusion in the classification 

regulation of the parent device (either 

via a premarket submission or via 

express inclusion in the language of the 

regulation or order) or via development 

of a unique, separate classification 

regulation or order for the accessory. 

For accessories of a new type, the 

guidance outlines the use of the de novo 

process for classification. This process 

provides a pathway to class I or class II 

classification for accessory devices for 

which general controls, or general and 

special controls, provide a reasonable 

assurance of safety and effectiveness, 

but for which there are no legally 

marketed predicate device. 

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 Agency’s current thinking 

on the regulation of medical device 

accessories. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

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 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Medical Device Accessories: 

Defining Accessories and Classification 

Pathway for New Accessory Types’’ may 

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

electronic copy of the document. Please 

use the document number 1770 to 

identify the guidance you are 

requesting. 


rljohnson on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 12 / Tuesday, January 20, 2015 / Notices 2711 

IV. Paperwork Reduction Act of 1995 

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. 

Accessory Classification De Novo 

Request—(OMB Control Number 0910– 

NEW) 

The draft guidance encourages 

manufacturers and other parties to 

utilize the process defined in section 

513(f)(2) of the FD&C Act to request 

risk-based classifications of new types 

of accessories. This process provides a 

pathway to class I or class II 

classification for accessory devices for 

which general controls, or general and 

special controls, provide a reasonable 

assurance of safety and effectiveness, 

but for which there is no legally 

marketed predicate device. 

In accordance with section 513(f)(2) of 

the FD&C Act, manufacturers and other 

parties may submit a de novo requesting 

FDA to make a classification 

determination for the accessory device 

according to the criteria in section 

513(a)(1) of the FD&C Act. The de novo 

must include a description of the device 

and detailed information and reasons 

for any recommended classification (see 

section 513(f)(2)(A)(v) of the FD&C Act). 

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 

Accessory classification de novo request ............................ 8 1 8 180 1,440 

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

Respondents are medical device 

manufacturers seeking to market device 

accessories. Of the approximately 41 de 

novo applications received per year, 

only two have been associated with 

accessories. With heightened awareness 

of the availability of the de novo 

pathway for accessories, we expect to 

receive four to six additional accessories 

applications per year. Therefore, we 

estimate that we will receive 

approximately eight accessory 

classification de novo requests per year. 

Based on estimates by FDA 

administrative and technical staff who 

are familiar with the proposed 

submission process for accessory 

classification requests and on our 

burden estimate for a similar 

information collection request (see ‘‘De 

Novo Classification Process Evaluation 

of Automatic Class III Designation; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; 

Availability,’’ 79 FR 47651 at 47653, 

August 14, 2014), we estimate that the 

submission process for each accessory 

classification request will take 

approximately 180 hours. 

The draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR parts 801 and 809 have been 

approved under OMB control number 

0910–0485; 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 860, subpart C, have been approved 

under OMB control number 0910–0138. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: January 12, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–00856 Filed 1–16–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–2153] 

Mitigating the Risk of CrossContamination From Valves and 

Accessories Used for Irrigation 

Through Flexible Gastrointestinal 

Endoscopes; Draft Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Mitigating the Risk of CrossContamination From Valves and 

Accessories Used for Irrigation Through 

Flexible Gastrointestinal Endoscopes.’’ 

FDA has received reports of blood and 

stool traveling through colonoscope 

irrigation channels and into the water 

bottle and tubing when the irrigation 

channel did not have a backflowprevention mechanism in place. This 

draft guidance document, when 

finalized, will highlight the crosscontamination risk associated with 


rljohnson on DSK3VPTVN1PROD with NOTICES