82_FR_129 82 FR 128 - Premarket Notification (510(k)) Submissions for Bone Anchors; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

82 FR 128 - Premarket Notification (510(k)) Submissions for Bone Anchors; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 1 (January 3, 2017)

Page Range128-129
FR Document2016-31779

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Premarket Notification (510(k)) Submissions for Bone Anchors.'' The guidance provides recommendations for the information and testing that should be included in premarket submissions for bone anchor (suture anchor) devices used in the appendicular skeleton for attachment of soft tissue to bone. This draft guidance is not final nor is it in effect at this time.

Federal Register, Volume 82 Issue 1 (Tuesday, January 3, 2017) 
[Federal Register Volume 82, Number 1 (Tuesday, January 3, 2017)]
[Notices]
[Pages 128-129]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31779]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4436]


Premarket Notification (510(k)) Submissions for Bone Anchors; 
Draft Guidance for Industry and Food and Drug Administration Staff; 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 or Agency) is announcing 
the availability of the draft guidance entitled ``Premarket 
Notification (510(k)) Submissions for Bone Anchors.'' The guidance 
provides recommendations for the information and testing that should be 
included in premarket submissions for bone anchor (suture anchor) 
devices used in the appendicular skeleton for attachment of soft tissue 
to bone. This draft guidance is not final nor is it in effect at this 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 6, 2017.

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-2016-D-4436 for ``Premarket Notification (510(k)) Submissions for 
Bone Anchors.'' 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 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 draft guidance document entitled 
``Premarket Notification (510(k)) Submissions for Bone Anchors'' 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: Daniel Ramsey, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1451, Silver Spring, MD 20993-0002, 301-796-6451.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled '''Premarket Notification (510(k)) Submissions 
for Bone Anchors.'' FDA has developed this guidance document for 
members of industry who submit and FDA staff who review premarket 
submissions regarding bone anchor (suture anchor) devices used in the 
appendicular skeleton for attachment of soft tissue to bone. When 
finalized, this guidance is intended to provide recommendations for 
information to include in premarket notifications (510(k)) for bone 
anchor (suture anchor) devices (e.g., descriptive characteristics, 
labeling, biocompatibility, sterility, and bench testing). This 
guidance is a reissuance of the April 20, 1996 ``Guidance Document for 
Testing Bone Anchor Devices'' with updated content.

[[Page 129]]

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 current thinking of FDA on Premarket 
Notification (510(k)) Submissions for Bone Anchors. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes 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 ``Premarket Notification 
(510(k)) Submissions for Bone Anchors'' may send an email request to 
[email protected] to receive an electronic copy of the 
document. Please use the document number 1400005 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). 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 820 have been approved under OMB control 
number 0910-0073; the collections of information in 21 CFR part 812 
have been approved under OMB control number 0910-0078; and the 
collections of information in 21 CFR part 801 have been approved under 
OMB control number 0910-0485.

    Dated: December 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31779 Filed 12-30-16; 8:45 am]
 BILLING CODE 4164-01-P

128 Federal Register / Vol. 82, No. 1 / Tuesday, January 3, 2017 / Notices Leroy A. Richardson, information, or other information that accordance with 21 CFR 10.20 and other Chief, Information Collection Review Office, identifies you in the body of your applicable disclosure law. For more Office of Scientific Integrity, Office of the comments, that information will be information about FDA’s posting of Associate Director for Science, Office of the posted on https://www.regulations.gov. comments to public dockets, see 80 FR Director, Centers for Disease Control and • If you want to submit a comment 56469, September 18, 2015, or access Prevention. with confidential information that you the information at: http://www.fda.gov/ [FR Doc. 2016–31773 Filed 12–30–16; 8:45 am] do not wish to be made available to the regulatoryinformation/dockets/ BILLING CODE 4163–18–P public, submit the comment as a default.htm. written/paper submission and in the Docket: For access to the docket to manner detailed (see ‘‘Written/Paper read background documents or the DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments HUMAN SERVICES received, go to https:// Written/Paper Submissions www.regulations.gov and insert the Food and Drug Administration Submit written/paper submissions as docket number, found in brackets in the [Docket No. FDA–2016–D–4436] follows: heading of this document, into the • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts Premarket Notification (510(k)) written/paper submissions): Division of and/or go to the Division of Dockets Submissions for Bone Anchors; Draft Dockets Management (HFA–305), Food Management, 5630 Fishers Lane, Rm. Guidance for Industry and Food and and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852. Drug Administration Staff; Availability Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of the guidance • For written/paper comments AGENCY: Food and Drug Administration, document is available for download submitted to the Division of Dockets HHS. Management, FDA will post your from the Internet. See the SUPPLEMENTARY INFORMATION section for ACTION: Notice of availability. comment, as well as any attachments, except for information submitted, information on electronic access to the SUMMARY: The Food and Drug marked and identified, as confidential, guidance. Submit written requests for a Administration (FDA or Agency) is if submitted as detailed in single hard copy of the draft guidance announcing the availability of the draft ‘‘Instructions.’’ document entitled ‘‘Premarket guidance entitled ‘‘Premarket Instructions: All submissions received Notification (510(k)) Submissions for Notification (510(k)) Submissions for must include the Docket No. FDA– Bone Anchors’’ to the Office of the Bone Anchors.’’ The guidance provides 2016–D–4436 for ‘‘Premarket Center Director, Guidance and Policy recommendations for the information Notification (510(k)) Submissions for Development, Center for Devices and and testing that should be included in Bone Anchors.’’ Received comments Radiological Health, Food and Drug premarket submissions for bone anchor will be placed in the docket and, except Administration, 10903 New Hampshire (suture anchor) devices used in the for those submitted as ‘‘Confidential Ave., Bldg. 66, Rm. 5431, Silver Spring, appendicular skeleton for attachment of Submissions,’’ publicly viewable at MD 20993–0002. Send one self- soft tissue to bone. This draft guidance https://www.regulations.gov or at the addressed adhesive label to assist that is not final nor is it in effect at this time. Division of Dockets Management office in processing your request. DATES: Although you can comment on between 9 a.m. and 4 p.m., Monday FOR FURTHER INFORMATION CONTACT: any guidance at any time (see 21 CFR through Friday. Daniel Ramsey, Center for Devices and 10.115(g)(5)), to ensure that the Agency • Confidential Submissions—To Radiological Health, Food and Drug considers your comment of this draft submit a comment with confidential Administration, 10903 New Hampshire guidance before it begins work on the information that you do not wish to be Ave., Bldg. 66, Rm. 1451, Silver Spring, final version of the guidance, submit made publicly available, submit your MD 20993–0002, 301–796–6451. either electronic or written comments comments only as a written/paper SUPPLEMENTARY INFORMATION: on the draft guidance by March 6, 2017. submission. You should submit two copies total. One copy will include the I. Background ADDRESSES: You may submit comments as follows: information you claim to be confidential FDA is announcing the availability of with a heading or cover note that states a draft guidance for industry and FDA Electronic Submissions ‘‘THIS DOCUMENT CONTAINS staff entitled ’’’Premarket Notification Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The (510(k)) Submissions for Bone following way: Agency will review this copy, including Anchors.’’ FDA has developed this • Federal eRulemaking Portal: the claimed confidential information, in guidance document for members of https://www.regulations.gov. Follow the its consideration of comments. The industry who submit and FDA staff who instructions for submitting comments. second copy, which will have the review premarket submissions regarding Comments submitted electronically, claimed confidential information bone anchor (suture anchor) devices including attachments, to https:// redacted/blacked out, will be available used in the appendicular skeleton for www.regulations.gov will be posted to for public viewing and posted on attachment of soft tissue to bone. When the docket unchanged. Because your https://www.regulations.gov. Submit finalized, this guidance is intended to comment will be made public, you are both copies to the Division of Dockets provide recommendations for solely responsible for ensuring that your Management. If you do not wish your information to include in premarket comment does not include any name and contact information to be notifications (510(k)) for bone anchor sradovich on DSK3GMQ082PROD with NOTICES confidential information that you or a made publicly available, you can (suture anchor) devices (e.g., descriptive third party may not wish to be posted, provide this information on the cover characteristics, labeling, such as medical information, your or sheet and not in the body of your biocompatibility, sterility, and bench anyone else’s Social Security number, or comments and you must identify this testing). This guidance is a reissuance of confidential business information, such information as ‘‘confidential.’’ Any the April 20, 1996 ‘‘Guidance Document as a manufacturing process. Please note information marked as ‘‘confidential’’ for Testing Bone Anchor Devices’’ with that if you include your name, contact will not be disclosed except in updated content. VerDate Sep<11>2014 22:14 Dec 30, 2016 Jkt 241001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\03JAN1.SGM 03JAN1

Federal Register / Vol. 82, No. 1 / Tuesday, January 3, 2017 / Notices 129 II. Significance of Guidance DEPARTMENT OF HEALTH AND anyone else’s Social Security number, or HUMAN SERVICES confidential business information, such This draft guidance is being issued as a manufacturing process. Please note consistent with FDA’s good guidance Food and Drug Administration that if you include your name, contact practices regulation (21 CFR 10.115). information, or other information that [Docket No. FDA–2013–N–1428] The draft guidance, when finalized, will identifies you in the body of your represent the current thinking of FDA Electronic Drug Product Reporting for comments, that information will be on Premarket Notification (510(k)) Human Drug Compounding posted on https://www.regulations.gov. Submissions for Bone Anchors. It does Outsourcing Facilities Under Section • If you want to submit a comment not establish any rights for any person 503B of the Federal Food, Drug, and with confidential information that you and is not binding on FDA or the public. Cosmetic Act; Guidance for Industry; do not wish to be made available to the You can use an alternative approach if Availability public, submit the comment as a it satisfies the requirements of the written/paper submission and in the AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper applicable statutes and regulations. HHS. Submissions’’ and ‘‘Instructions’’). III. Electronic Access ACTION: Notice of availability. Written/Paper Submissions Persons interested in obtaining a copy SUMMARY: The Food and Drug Submit written/paper submissions as of the draft guidance may do so by Administration (FDA or the Agency) is follows: downloading an electronic copy from announcing the availability of a • Mail/Hand delivery/Courier (for the Internet. A search capability for all guidance for industry entitled written/paper submissions): Division of Center for Devices and Radiological ‘‘Electronic Drug Product Reporting for Dockets Management (HFA–305), Food Health guidance documents is available Human Drug Compounding Outsourcing and Drug Administration, 5630 Fishers Facilities Under Section 503B of the Lane, Rm. 1061, Rockville, MD 20852. at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Federal Food, Drug, and Cosmetic Act.’’ • For written/paper comments The final guidance addresses new submitted to the Division of Dockets GuidanceDocuments/default.htm. provisions in the Federal Food, Drug, Management, FDA will post your Guidance documents are also available and Cosmetic Act (the FD&C Act) added comment, as well as any attachments, at https://www.regulations.gov. Persons by the Drug Quality and Security Act except for information submitted, unable to download an electronic copy (DQSA) and updates reporting marked and identified, as confidential, of ‘‘Premarket Notification (510(k)) instructions for drug compounders that if submitted as detailed in Submissions for Bone Anchors’’ may choose to register as outsourcing ‘‘Instructions.’’ send an email request to CDRH- facilities. Such compounders must Instructions: All submissions received Guidance@fda.hhs.gov to receive an report information on the drugs they must include the Docket No. FDA– electronic copy of the document. Please compounded in Structured Product 2013–N–1428 for ‘‘Electronic Drug use the document number 1400005 to Labeling (SPL) format using FDA’s Product Reporting for Human Drug identify the guidance you are electronic submissions system unless Compounding Outsourcing Facilities requesting. FDA grants a request for a waiver of Under Section 503B of the Federal such requirement because use of Food, Drug, and Cosmetic Act.’’ IV. Paperwork Reduction Act of 1995 electronic means is not reasonable for Received comments will be placed in This draft guidance refers to the person requesting the waiver. This the docket and, except for those previously approved collections of guidance supersedes the revised draft submitted as ‘‘Confidential information found in FDA regulations. guidance entitled ‘‘Electronic Drug Submissions,’’ publicly viewable at These collections of information are Product Reporting for Human Drug https://www.regulations.gov or at the Compounding Outsourcing Facilities Division of Dockets Management subject to review by the Office of Under Section 503B of the Federal between 9 a.m. and 4 p.m., Monday Management and Budget (OMB) under Food, Drug, and Cosmetic Act.’’ through Friday. the Paperwork Reduction Act of 1995 • Confidential Submissions—To DATES: Submit either electronic or (44 U.S.C. 3501–3520). The collections submit a comment with confidential written comments on Agency guidances of information in 21 CFR part 807, information that you do not wish to be at any time. subpart E have been approved under made publicly available, submit your ADDRESSES: You may submit comments OMB control number 0910–0120; the comments only as a written/paper as follows: collections of information in 21 CFR submission. You should submit two part 820 have been approved under Electronic Submissions copies total. One copy will include the OMB control number 0910–0073; the Submit electronic comments in the information you claim to be confidential collections of information in 21 CFR following way: with a heading or cover note that states part 812 have been approved under • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS OMB control number 0910–0078; and https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The the collections of information in 21 CFR instructions for submitting comments. Agency will review this copy, including part 801 have been approved under Comments submitted electronically, the claimed confidential information, in OMB control number 0910–0485. including attachments, to https:// its consideration of comments. The www.regulations.gov will be posted to second copy, which will have the sradovich on DSK3GMQ082PROD with NOTICES Dated: December 27, 2016. the docket unchanged. Because your claimed confidential information Leslie Kux, comment will be made public, you are redacted/blacked out, will be available Associate Commissioner for Policy. solely responsible for ensuring that your for public viewing and posted on http:// [FR Doc. 2016–31779 Filed 12–30–16; 8:45 am] comment does not include any www.regulations.gov. Submit both BILLING CODE 4164–01–P confidential information that you or a copies to the Division of Dockets third party may not wish to be posted, Management. If you do not wish your such as medical information, your or name and contact information to be VerDate Sep<11>2014 22:14 Dec 30, 2016 Jkt 241001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\03JAN1.SGM 03JAN1


Document Created: 2018-02-01 14:44:17
Document Modified: 2018-02-01 14:44:17
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesAlthough 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 March 6, 2017.
ContactDaniel Ramsey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1451, Silver Spring, MD 20993-0002, 301-796-6451.
FR Citation82 FR 128 
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