Source: https://regulations.justia.com/regulations/fedreg/2016/12/30/2016-31669.html
Timestamp: 2020-08-11 13:47:38
Document Index: 565595470

Matched Legal Cases: ['§ 101', '§ 101', '§ 101', 'arts 801', 'art 807', 'art 814', 'art 860', 'art 581', 'art 581', 'arts 801', 'art 807', 'art 814', 'art 860']

Medical Device Accessories-Describing Accessories and Classification Pathway for New Accessory Types; Guidance for Industry and Food and Drug Administration Staff; Availability, 96467-96469 [2016-31669] :: Food And Drug Administration :: Department Of Health And Human Services :: Regulation Tracker :: Justia
Justia Regulation Tracker Department Of Health And Human Services Food And Drug Administration Medical Device Accessories-Describing Accessories and Classification Pathway for New Accessory Types; Guidance for Industry and Food and Drug Administration Staff; Availability, 96467-96469 [2016-31669]
Medical Device Accessories-Describing Accessories and Classification Pathway for New Accessory Types; Guidance for Industry and Food and Drug Administration Staff; Availability, 96467-96469 [2016-31669]
Download as PDF 96467 Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of responses per respondent Number of respondents 21 CFR section/Form No. Average burden per response Total annual responses Total hours 101.108; written proposal for requesting temporary exemptions from certain regulations for the purpose of conducting 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 disclosure, recordkeeping, and reporting burdens are based on our communications with industry and our knowledge of and experience with food labeling and the submission of petitions and requests to us. We expect that the burden hours for submissions under § 101.108 will be insignificant. Section 101.108 was originally issued to provide a procedure whereby we could grant exemptions from certain food labeling requirements. Exemption petitions have infrequently been submitted in the recent past; none have been submitted since publication on January 6, 1993, of the final regulations implementing section 403(q) and (r) of the FD&C Act. Thus, in order to maintain OMB approval of § 101.108 to accommodate the possibility that a food producer may propose to conduct a labeling experiment on its own initiative, we estimate that we will receive one or fewer submissions under § 101.108 in the next 3 years. Dated: December 27, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–31733 Filed 12–29–16; 8:45 am] BILLING CODE 4164–01–P 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 srobinson on DSK5SPTVN1PROD with NOTICES AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Medical Device Accessories— Describing Accessories and SUMMARY: VerDate Sep<11>2014 19:18 Dec 29, 2016 Jkt 241001 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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 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 E:\FR\FM\30DEN1.SGM 30DEN1 96468 Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices 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 selfaddressed 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: srobinson on DSK5SPTVN1PROD with NOTICES 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. VerDate Sep<11>2014 19:18 Dec 29, 2016 Jkt 241001 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 controlbased 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 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 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 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. 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 E:\FR\FM\30DEN1.SGM 30DEN1 Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices have been approved under OMB control number 0910–0823. DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT Dated: December 23, 2016. Leslie Kux, Associate Commissioner for Policy. [Docket No. FR–5907–N–53] Federal Property Suitable as Facilities To Assist the Homeless [FR Doc. 2016–31669 Filed 12–29–16; 8:45 am] Office of the Assistant Secretary for Community Planning and Development, HUD. ACTION: Notice. AGENCY: BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Statement of Organization, Functions, and Delegations of Authority Part N, National Institutes of Health (NIH), of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (40 FR 22859, May 27, 1975, as amended most recently at 77 FR 1941, January 12, 2012, and redesignated from Part HN as Part N at 60 FR 56605, November 9, 1995), is amended as set forth below to establish the All of UsSM Research Program Office. Section N–A, Organization and Functions, is amended as follows: Immediately after the paragraph headed ‘‘Office of the Director’’(OD), insert the following: All Of Us Research Program Office srobinson on DSK5SPTVN1PROD with NOTICES (HNAK) (1) Oversees the design, development, implementation, and evaluation of the All of Us Resesarch Program, creating the largest and most diverse research cohort of its kind, to foster a new era of medicine in which researchers, providers and patients work together to develop individualized care by supporting research into the complex factors promoting health and treatments to cure disease. Delegations of Authority Statement: All delegations and redelegations of authority to officers and employees of the NIH that were in effect immediately prior to the effective date of this reorganization and are consistent with this reorganization shall continue in effect, pending further redelegation. Dated: December 23, 2016. Francis S. Collins, Director, National Institutes of Health. [FR Doc. 2016–31687 Filed 12–29–16; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 19:18 Dec 29, 2016 Jkt 241001 This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for use to assist the homeless. FOR FURTHER INFORMATION CONTACT: Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7266, Washington, DC 20410; telephone (202) 402–3970; TTY number for the hearing- and speechimpaired (202) 708–2565 (these telephone numbers are not toll-free), call the toll-free Title V information line at 800–927–7588 or send an email to title5@hud.gov . SUPPLEMENTARY INFORMATION: In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in National Coalition for the Homeless v. Veterans Administration, No. 88–2503– OG (D.D.C.). Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/ unavailable, and suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency’s needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless. Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days SUMMARY: National Institutes of Health PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 96469 from the date of this Notice. Where property is described as for ‘‘off-site use only’’ recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to: Ms. Theresa M. Ritta, Chief Real Property Branch, the Department of Health and Human Services, Room 12–07, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, (301)-443–2265 (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581. For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/ available or suitable/unavailable. For properties listed as suitable/ unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available. Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1– 800–927–7588 or send an email to title5@hud.gov for detailed instructions, or write a letter to Ann Marie Oliva at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the Federal Register, the landholding agency, and the property number. For more information regarding particular properties identified in this Notice (e.g., acreage, floor plan, condition of property, existing sanitary facilities, exact street address), providers should contact the appropriate landholding agencies at the following address(es): AGRICULTURE: Ms. Debra Kerr, Department of E:\FR\FM\30DEN1.SGM 30DEN1
[Pages 96467-96469]
[FR Doc No: 2016-31669]
[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
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)).
FDA-2015-D-0025 for ``Medical Device Accessories--Describing
Accessories and Classification Pathway for New Accessory Types.''
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
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
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
``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
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
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353 or
Drug Administration, 10903 New Hampshire Ave,. Bldg. 71, Rm. 7301,
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.
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
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 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.
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
[[Page 96469]]
have been approved under OMB control number 0910-0823.
[FR Doc. 2016-31669 Filed 12-29-16; 8:45 am]