[Federal Register Volume 80, Number 12 (Tuesday, January 20, 2015)]
[Notices]
[Pages 2710-2711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-00856]


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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Classification Pathway for New Accessory Types; Draft Guidance for 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.

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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availability of the draft guidance entitled ``Medical Device 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 risk-based 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 This draft guidance is not final nor is it in 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 20, 2015.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requests for a single hard copy of the draft guidance document entitled 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 self-addressed 
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 [email protected] to receive an electronic copy of 
the document. Please use the document number 1770 to identify the 
guidance you are requesting.

[[Page 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\
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                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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Accessory classification de novo request...........................               8                1                8              180            1,440
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\1\ There 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