[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Notices]
[Pages 96467-96469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31669]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0025]


Medical Device Accessories--Describing Accessories and 
Classification Pathway for New Accessory Types; Guidance for Industry 
and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Medical Device Accessories--
Describing Accessories and Classification Pathways for New Accessory 
Types.'' This document provides guidance to industry and FDA staff 
about the regulation of accessories to medical devices. The guidance 
explains what devices FDA generally considers an ``accessory'' and 
encourages use of the de novo classification process under the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) to allow manufacturers and 
other parties to request risk- and regulatory control-based 
classification of accessories of a new type (i.e., accessories of a 
type that has not been previously classified under the FD&C Act, 
cleared for marketing under a 510(k) submission, or approved in an 
application for premarket approval (PMA)).

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-D-0025 for ``Medical Device Accessories--Describing 
Accessories and Classification Pathway for New Accessory Types.'' 
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 Division of Dockets Management 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 Division of Dockets Management. If you do not 
wish your name and contact information to be

[[Page 96468]]

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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 
``Medical Device Accessories--Describing 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.

FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353 or 
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

    FDA has jurisdiction over accessories because the definition of the 
term ``device'' provided in section 201(h) of the FD&C Act defines 
``device'' to include, among other things, an ``accessory.'' All 
accessories to articles that meet this definition of ``device'' are 
regulated under the FD&C Act.
    This guidance is intended to provide guidance to industry and FDA 
staff about the regulation of accessories to medical devices. 
Accordingly, this guidance describes the types of devices that FDA 
generally considers as accessories and discusses the risk- and 
regulatory control-based classification paradigm for these accessories. 
This information is expected to provide a greater level of transparency 
with regards to the classification of accessories and will aid FDA 
staff and industry in assuring that these devices are subject to an 
appropriate level of regulatory oversight by FDA. In addition, this 
guidance describes the use of the de novo classification process under 
section 513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)) for 
manufacturers to request risk- and regulatory control-based 
classifications of accessories of a new type that are low-moderate risk 
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.
    For the purposes of this guidance document, an ``accessory'' is 
defined as ``a finished device that is intended to support, supplement, 
and/or augment the performance of one or more parent devices.'' It is 
important to note that FDA does not generally consider articles that do 
not meet the definition of an accessory as accessories simply because 
they may be used in conjunction with a device.
    This guidance clarifies that classification of accessory devices, 
as for non-accessory devices, should reflect the risks of the device 
when used as intended and the level of regulatory controls necessary to 
provide a reasonable assurance of safety and effectiveness. Classifying 
an accessory in the same class as its parent device is appropriate when 
the accessory, when used as intended with the parent device, meets the 
criteria for placement in the class of the parent device. However, some 
accessories can have a lower risk profile than that of their parent 
device and, therefore, may warrant being regulated in a lower class.
    In the Federal Register of January 20, 2015 (80 FR 2710), FDA 
published a notice of availability for the draft guidance entitled 
``Medical Device Accessories: Defining Accessories and Classification 
Pathway for New Accessory Types.'' FDA revised the guidance as 
appropriate in response to the comments. We received comments 
requesting that the scope of the guidance be expanded to apply to 
existing accessories that were previously classified. FDA is continuing 
to explore mechanisms for risk- and regulatory control-based 
reclassification of existing accessories. Therefore, the scope of the 
guidance has not been expanded and includes the use of the de novo 
classification process to classify accessories of a new type.

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 
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 Center for Devices and Radiological Health guidance 
documents is available at http://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 ``Medical Device Accessories: 
Describing 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.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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. The 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; the collections of information in 21 CFR part 860, 
subpart C have been approved under OMB control number 0910-0138; and 
the collection of information for new medical device accessories 
devices

[[Page 96469]]

have been approved under OMB control number 0910-0823.

    Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31669 Filed 12-29-16; 8:45 am]
 BILLING CODE 4164-01-P