Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 2710-2711 [2015-00856]

Download as PDF 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FDA–2015–D–0025] Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.’’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 This draft guidance is not final nor is it in effect at this time.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 20, 2015.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 rljohnson on DSK3VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:47 Jan 16, 2015 Jkt 235001 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 Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types’’ to the Office of the Center Director,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 https:// 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 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 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 ‘‘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. E:\FR\FM\20JAN1.SGM 20JAN1 2711 Federal Register / Vol. 80, No. 12 / Tuesday, January 20, 2015 / Notices 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 rljohnson on DSK3VPTVN1PROD with NOTICES 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 VerDate Sep<11>2014 14:47 Jan 16, 2015 Jkt 235001 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 https://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 https:// 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 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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. 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 SUMMARY: E:\FR\FM\20JAN1.SGM 20JAN1

Agencies

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

-----------------------------------------------------------------------

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 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 https://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 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 ``Medical Device Accessories: Defining Accessories and
Classification Pathway for New Accessory Types'' may send an email
request to CDRH-Guidance@fda.hhs.gov 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Accessory classification de novo request........................... 8 1 8 180 1,440
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 https://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 https://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

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