81 FR 96467 - Medical Device Accessories-Describing Accessories and Classification Pathway for New Accessory Types; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 251 (December 30, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 251 (December 30, 2016)
| Page Range | 96467-96469 | |
| FR Document | 2016-31669 |
[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)] [Notices] [Pages 96467-96469] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31669] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices 96467
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of Total annual
21 CFR section/Form No. responses per burden per Total hours
respondents responses
respondent response
101.108; written proposal for requesting temporary exemp-
tions from certain regulations for the purpose of con-
ducting food labeling experiments ................................... 1 1 1 40 40
Total .............................................................................. ........................ ........................ ........................ ........................ 80,915
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated annual third party Classification Pathways for New public, submit the comment as a
disclosure, recordkeeping, and reporting Accessory Types.’’ This document written/paper submission and in the
burdens are based on our provides guidance to industry and FDA manner detailed (see ‘‘Written/Paper
communications with industry and our staff about the regulation of accessories Submissions’’ and ‘‘Instructions’’).
knowledge of and experience with food to medical devices. The guidance Written/Paper Submissions
labeling and the submission of petitions explains what devices FDA generally
and requests to us. considers an ‘‘accessory’’ and Submit written/paper submissions as
We expect that the burden hours for encourages use of the de novo follows:
submissions under § 101.108 will be classification process under the Federal • Mail/Hand delivery/Courier (for
insignificant. Section 101.108 was Food, Drug, and Cosmetic Act (the written/paper submissions): Division of
originally issued to provide a procedure FD&C Act) to allow manufacturers and Dockets Management (HFA–305), Food
whereby we could grant exemptions other parties to request risk- and and Drug Administration, 5630 Fishers
from certain food labeling requirements. regulatory control-based classification of Lane, Rm. 1061, Rockville, MD 20852.
Exemption petitions have infrequently accessories of a new type (i.e., • For written/paper comments
submitted to the Division of Dockets
been submitted in the recent past; none accessories of a type that has not been
Management, FDA will post your
have been submitted since publication previously classified under the FD&C
comment, as well as any attachments,
on January 6, 1993, of the final Act, cleared for marketing under a
except for information submitted,
regulations implementing section 403(q) 510(k) submission, or approved in an
marked and identified, as confidential,
and (r) of the FD&C Act. Thus, in order application for premarket approval
if submitted as detailed in
to maintain OMB approval of § 101.108 (PMA)).
‘‘Instructions.’’
to accommodate the possibility that a DATES: Submit either electronic or Instructions: All submissions received
food producer may propose to conduct written comments on this guidance at must include the Docket No. FDA–
a labeling experiment on its own any time. General comments on Agency 2015–D–0025 for ‘‘Medical Device
initiative, we estimate that we will guidance documents are welcome at any Accessories—Describing Accessories
receive one or fewer submissions under time. and Classification Pathway for New
§ 101.108 in the next 3 years. ADDRESSES: You may submit comments Accessory Types.’’ Received comments
Dated: December 27, 2016. as follows: will be placed in the docket and, except
Leslie Kux, for those submitted as ‘‘Confidential
Electronic Submissions Submissions,’’ publicly viewable at
Associate Commissioner for Policy.
[FR Doc. 2016–31733 Filed 12–29–16; 8:45 am] Submit electronic comments in the https://www.regulations.gov or at the
BILLING CODE 4164–01–P
following way: Division of Dockets Management
• Federal eRulemaking Portal: between 9 a.m. and 4 p.m., Monday
https://www.regulations.gov. Follow the through Friday.
DEPARTMENT OF HEALTH AND instructions for submitting comments. • Confidential Submissions—To
HUMAN SERVICES Comments submitted electronically, submit a comment with confidential
including attachments, to https:// information that you do not wish to be
Food and Drug Administration www.regulations.gov will be posted to made publicly available, submit your
the docket unchanged. Because your comments only as a written/paper
[Docket No. FDA–2015–D–0025] comment will be made public, you are submission. You should submit two
Medical Device Accessories— solely responsible for ensuring that your copies total. One copy will include the
comment does not include any information you claim to be confidential
Describing Accessories and
confidential information that you or a with a heading or cover note that states
Classification Pathway for New
third party may not wish to be posted, ‘‘THIS DOCUMENT CONTAINS
Accessory Types; Guidance for
such as medical information, your or CONFIDENTIAL INFORMATION.’’ The
Industry and Food and Drug
anyone else’s Social Security number, or Agency will review this copy, including
Administration Staff; Availability
confidential business information, such the claimed confidential information, in
AGENCY: Food and Drug Administration, as a manufacturing process. Please note its consideration of comments. The
HHS. that if you include your name, contact second copy, which will have the
srobinson on DSK5SPTVN1PROD with NOTICES
ACTION: Notice of availability. information, or other information that claimed confidential information
identifies you in the body of your redacted/blacked out, will be available
SUMMARY: The Food and Drug comments, that information will be for public viewing and posted on
Administration (FDA) is announcing the posted on https://www.regulations.gov. https://www.regulations.gov. Submit
availability of the guidance entitled • If you want to submit a comment both copies to the Division of Dockets
‘‘Medical Device Accessories— with confidential information that you Management. If you do not wish your
Describing Accessories and do not wish to be made available to the name and contact information to be
VerDate Sep<11>2014 19:18 Dec 29, 2016 Jkt 241001 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1](https://thefederalregister.org/doc/81_FR_96718/page/1.svg)
![Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices 96469
have been approved under OMB control DEPARTMENT OF HOUSING AND from the date of this Notice. Where
number 0910–0823. URBAN DEVELOPMENT property is described as for ‘‘off-site use
Dated: December 23, 2016.
only’’ recipients of the property will be
[Docket No. FR–5907–N–53]
required to relocate the building to their
Leslie Kux, own site at their own expense.
Associate Commissioner for Policy.
Federal Property Suitable as Facilities
To Assist the Homeless Homeless assistance providers
[FR Doc. 2016–31669 Filed 12–29–16; 8:45 am] interested in any such property should
BILLING CODE 4164–01–P AGENCY: Office of the Assistant send a written expression of interest to
Secretary for Community Planning and HHS, addressed to: Ms. Theresa M.
Development, HUD. Ritta, Chief Real Property Branch, the
DEPARTMENT OF HEALTH AND ACTION: Notice. Department of Health and Human
HUMAN SERVICES Services, Room 12–07, Parklawn
SUMMARY: This Notice identifies Building, 5600 Fishers Lane, Rockville,
National Institutes of Health unutilized, underutilized, excess, and MD 20857, (301)-443–2265 (This is not
surplus Federal property reviewed by a toll-free number.) HHS will mail to the
National Institutes of Health Statement HUD for suitability for use to assist the interested provider an application
of Organization, Functions, and homeless. packet, which will include instructions
Delegations of Authority FOR FURTHER INFORMATION CONTACT: for completing the application. In order
Juanita Perry, Department of Housing to maximize the opportunity to utilize a
Part N, National Institutes of Health and Urban Development, 451 Seventh suitable property, providers should
(NIH), of the Statement of Organization, Street SW., Room 7266, Washington, DC submit their written expressions of
Functions, and Delegations of Authority 20410; telephone (202) 402–3970; TTY interest as soon as possible. For
for the Department of Health and number for the hearing- and speech- complete details concerning the
Human Services (40 FR 22859, May 27, impaired (202) 708–2565 (these processing of applications, the reader is
1975, as amended most recently at 77 telephone numbers are not toll-free), encouraged to refer to the interim rule
FR 1941, January 12, 2012, and call the toll-free Title V information line governing this program, 24 CFR part
redesignated from Part HN as Part N at at 800–927–7588 or send an email to 581.
60 FR 56605, November 9, 1995), is title5@hud.gov . For properties listed as suitable/to be
excess, that property may, if
amended as set forth below to establish SUPPLEMENTARY INFORMATION: In
subsequently accepted as excess by
the All of UsSM Research Program accordance with 24 CFR part 581 and GSA, be made available for use by the
Office. section 501 of the Stewart B. McKinney homeless in accordance with applicable
Section N–A, Organization and Homeless Assistance Act (42 U.S.C. law, subject to screening for other
Functions, is amended as follows: 11411), as amended, HUD is publishing Federal use. At the appropriate time,
Immediately after the paragraph headed this Notice to identify Federal buildings HUD will publish the property in a
‘‘Office of the Director’’(OD), insert the and other real property that HUD has Notice showing it as either suitable/
reviewed for suitability for use to assist available or suitable/unavailable.
following:
the homeless. The properties were For properties listed as suitable/
All Of Us Research Program Office reviewed using information provided to unavailable, the landholding agency has
HUD by Federal landholding agencies decided that the property cannot be
(HNAK) (1) Oversees the design, regarding unutilized and underutilized declared excess or made available for
development, implementation, and buildings and real property controlled use to assist the homeless, and the
evaluation of the All of Us Resesarch by such agencies or by GSA regarding property will not be available.
Program, creating the largest and most its inventory of excess or surplus Properties listed as unsuitable will
diverse research cohort of its kind, to Federal property. This Notice is also not be made available for any other
foster a new era of medicine in which published in order to comply with the purpose for 20 days from the date of this
researchers, providers and patients work December 12, 1988 Court Order in Notice. Homeless assistance providers
together to develop individualized care National Coalition for the Homeless v. interested in a review by HUD of the
by supporting research into the complex Veterans Administration, No. 88–2503– determination of unsuitability should
factors promoting health and treatments OG (D.D.C.). call the toll free information line at 1–
to cure disease. Properties reviewed are listed in this 800–927–7588 or send an email to
Notice according to the following title5@hud.gov for detailed instructions,
Delegations of Authority Statement:
categories: Suitable/available, suitable/ or write a letter to Ann Marie Oliva at
All delegations and redelegations of
unavailable, and suitable/to be excess, the address listed at the beginning of
authority to officers and employees of and unsuitable. The properties listed in this Notice. Included in the request for
the NIH that were in effect immediately the three suitable categories have been review should be the property address
prior to the effective date of this reviewed by the landholding agencies, (including zip code), the date of
reorganization and are consistent with and each agency has transmitted to publication in the Federal Register, the
this reorganization shall continue in HUD: (1) Its intention to make the landholding agency, and the property
effect, pending further redelegation. property available for use to assist the number.
Dated: December 23, 2016. homeless, (2) its intention to declare the For more information regarding
property excess to the agency’s needs, or particular properties identified in this
srobinson on DSK5SPTVN1PROD with NOTICES
Francis S. Collins,
(3) a statement of the reasons that the Notice (e.g., acreage, floor plan,
Director, National Institutes of Health.
property cannot be declared excess or condition of property, existing sanitary
[FR Doc. 2016–31687 Filed 12–29–16; 8:45 am]
made available for use as facilities to facilities, exact street address),
BILLING CODE 4140–01–P assist the homeless. providers should contact the
Properties listed as suitable/available appropriate landholding agencies at the
will be available exclusively for following address(es): AGRICULTURE:
homeless use for a period of 60 days Ms. Debra Kerr, Department of
VerDate Sep<11>2014 19:18 Dec 29, 2016 Jkt 241001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\30DEN1.SGM 30DEN1](https://thefederalregister.org/doc/81_FR_96718/page/3.svg)
Document Created: 2016-12-30 05:16:10
Document Modified: 2016-12-30 05:16:10
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| 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. | |
| FR Citation | 81 FR 96467 |
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