83 FR 27998 - Coronary, Peripheral, and Neurovascular Guidewires-Performance Tests and Recommended Labeling; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 116 (June 15, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 116 (June 15, 2018)
| Page Range | 27998-27999 | |
| FR Document | 2018-12825 |
[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)] [Notices] [Pages 27998-27999] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12825] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-1775] Coronary, Peripheral, and Neurovascular Guidewires--Performance Tests and Recommended Labeling; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Coronary, Peripheral, and Neurovascular Guidewires--Performance Tests and Recommended Labeling.'' This draft guidance provides recommendations for the information and testing that should be included in premarket submissions for guidewires intended for use in the coronary, peripheral, and neurovasculature. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by August 14, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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-2018-D-1775 for ``Coronary, Peripheral, and Neurovascular Guidewires--Performance Tests and Recommended Labeling.'' 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 Dockets Management Staff 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 Dockets Management Staff. 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 [[Page 27999]] 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). 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 entitled ``Coronary, Peripheral, and Neurovascular Guidewires--Performance Tests and Recommended Labeling'' 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: Jismi Johnson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993-0002, 301-796-6424. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry and FDA staff entitled ``Coronary, Peripheral, and Neurovascular Guidewires--Performance Tests and Recommended Labeling.'' This draft guidance updates and clarifies performance testing and labeling recommendations to support a premarket notification (510(k) submission) for guidewires intended for use in the coronary, peripheral, and neurovasculature. This draft guidance is intended to assist industry in designing and executing appropriate performance testing to support a premarket notification and provides recommendations for content and labeling to include in the submission. When final, this guidance will replace ``Coronary and Cerebrovascular Guidewire Guidance'' (https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080789.pdf) dated January 1995. 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 ``Coronary, Peripheral and Neurovascular Guidewires--Performance Tests and Recommended Labeling.'' 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. This guidance is not subject to Executive Order 12866. 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft guidance is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ``Coronary, Peripheral, and Neurovascular Guidewires--Performance Tests and Recommended Labeling'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 16007 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 and guidance. 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; the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485; and the collections of information in the guidance document ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' have been approved under OMB control number 0910-0756. Dated: June 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-12825 Filed 6-14-18; 8:45 am] BILLING CODE 4164-01-P
![27998 Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices
guidance is to provide been approved under OMB control that if you include your name, contact
recommendations for information to be number 0910–0485. information, or other information that
included in device labeling, as Dated: June 8, 2018. identifies you in the body of your
submitted in PMAs or 510(k)s for class Leslie Kux,
comments, that information will be
III and class II devices, to enhance the posted on https://www.regulations.gov.
Associate Commissioner for Policy. • If you want to submit a comment
consistency of coating information
[FR Doc. 2018–12824 Filed 6–14–18; 8:45 am] with confidential information that you
across these product areas as well as to
promote the safe use of these devices in BILLING CODE 4164–01–P do not wish to be made available to the
clinical settings. public, submit the comment as a
written/paper submission and in the
II. Significance of Guidance DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
This draft guidance is being issued
consistent with FDA’s good guidance Food and Drug Administration Written/Paper Submissions
practices regulation (21 CFR 10.115).
[Docket No. FDA–2018–D–1775] Submit written/paper submissions as
The draft guidance, when finalized, will
follows:
represent the current thinking of FDA
Coronary, Peripheral, and • Mail/Hand delivery/Courier (for
on ‘‘Intravascular Catheters, Wires, and written/paper submissions): Dockets
Neurovascular Guidewires—
Delivery Systems with Lubricious Management Staff (HFA–305), Food and
Performance Tests and Recommended
Coatings—Labeling Considerations.’’ It Drug Administration, 5630 Fishers
Labeling; Draft Guidance for Industry
does not establish any rights for any Lane, Rm. 1061, Rockville, MD 20852.
and Food and Drug Administration
person and is not binding on FDA or the • For written/paper comments
Staff; Availability
public. You can use an alternative submitted to the Dockets Management
approach if it satisfies the requirements AGENCY: Food and Drug Administration, Staff, FDA will post your comment, as
of the applicable statutes and HHS. well as any attachments, except for
regulations. This guidance is not subject ACTION: Notice of availability. information submitted, marked and
to Executive Order 12866. identified, as confidential, if submitted
SUMMARY: The Food and Drug as detailed in ‘‘Instructions.’’
III. Electronic Access Administration (FDA or Agency) is Instructions: All submissions received
Persons interested in obtaining a copy announcing the availability of the draft must include the Docket No. FDA–
of the draft guidance may do so by guidance entitled ‘‘Coronary, Peripheral, 2018–D–1775 for ‘‘Coronary, Peripheral,
downloading an electronic copy from and Neurovascular Guidewires— and Neurovascular Guidewires—
the internet. A search capability for all Performance Tests and Recommended Performance Tests and Recommended
Center for Devices and Radiological Labeling.’’ This draft guidance provides Labeling.’’ Received comments will be
Health guidance documents is available recommendations for the information placed in the docket and, except for
at https://www.fda.gov/MedicalDevices/ and testing that should be included in those submitted as ‘‘Confidential
DeviceRegulationandGuidance/ premarket submissions for guidewires Submissions,’’ publicly viewable at
GuidanceDocuments/default.htm. This intended for use in the coronary, https://www.regulations.gov or at the
draft guidance document is also peripheral, and neurovasculature. This Dockets Management Staff between 9
available at https:// draft guidance is not final nor is it in a.m. and 4 p.m., Monday through
www.regulations.gov. Persons unable to effect at this time. Friday.
download an electronic copy of DATES: Submit either electronic or • Confidential Submissions—To
‘‘Intravascular Catheters, Wires, and written comments on the draft guidance submit a comment with confidential
Delivery Systems with Lubricious by August 14, 2018 to ensure that the information that you do not wish to be
Coatings—Labeling Considerations’’ Agency considers your comment on this made publicly available, submit your
may send an email request to CDRH- draft guidance before it begins work on comments only as a written/paper
Guidance@fda.hhs.gov to receive an the final version of the guidance. submission. You should submit two
electronic copy of the document. Please ADDRESSES: You may submit comments copies total. One copy will include the
use the document number 16016 to on any guidance at any time as follows: information you claim to be confidential
identify the guidance you are with a heading or cover note that states
requesting. Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
IV. Paperwork Reduction Act of 1995 Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
following way: Agency will review this copy, including
This draft guidance refers to • Federal eRulemaking Portal: the claimed confidential information, in
previously approved collections of https://www.regulations.gov. Follow the its consideration of comments. The
information found in FDA regulations. instructions for submitting comments. second copy, which will have the
These collections of information are Comments submitted electronically, claimed confidential information
subject to review by the Office of including attachments, to https:// redacted/blacked out, will be available
Management and Budget (OMB) under www.regulations.gov will be posted to for public viewing and posted on
the Paperwork Reduction Act of 1995 the docket unchanged. Because your https://www.regulations.gov. Submit
(44 U.S.C. 3501–3520). The collections comment will be made public, you are both copies to the Dockets Management
of information in 21 CFR part 807, solely responsible for ensuring that your Staff. If you do not wish your name and
sradovich on DSK3GMQ082PROD with NOTICES
subpart E have been approved under comment does not include any contact information to be made publicly
OMB control number 0910–0120; the confidential information that you or a available, you can provide this
collections of information in 21 CFR third party may not wish to be posted, information on the cover sheet and not
part 814, subparts A through E have such as medical information, your or in the body of your comments and you
been approved under OMB control anyone else’s Social Security number, or must identify this information as
number 0910–0231; and the collections confidential business information, such ‘‘confidential.’’ Any information marked
of information in 21 CFR part 801 have as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
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![Federal Register / Vol. 83, No. 116 / Friday, June 15, 2018 / Notices 27999
except in accordance with 21 CFR 10.20 When final, this guidance will replace the collections of information in the
and other applicable disclosure law. For ‘‘Coronary and Cerebrovascular guidance document ‘‘Requests for
more information about FDA’s posting Guidewire Guidance’’ (https:// Feedback on Medical Device
of comments to public dockets, see 80 www.fda.gov/downloads/Medical Submissions: The Pre-Submission
FR 56469, September 18, 2015, or access Devices/DeviceRegulationandGuidance/ Program and Meetings with Food and
the information at: https://www.gpo.gov/ GuidanceDocuments/UCM080789.pdf) Drug Administration Staff’’ have been
fdsys/pkg/FR-2015-09-18/pdf/2015- dated January 1995. approved under OMB control number
23389.pdf. II. Significance of Guidance 0910–0756.
Docket: For access to the docket to Dated: June 8, 2018.
read background documents or the This draft guidance is being issued
consistent with FDA’s good guidance Leslie Kux,
electronic and written/paper comments
practices regulation (21 CFR 10.115). Associate Commissioner for Policy.
received, go to https://
www.regulations.gov and insert the The draft guidance, when finalized, will [FR Doc. 2018–12825 Filed 6–14–18; 8:45 am]
docket number, found in brackets in the represent the current thinking of FDA BILLING CODE 4164–01–P
heading of this document, into the on ‘‘Coronary, Peripheral and
‘‘Search’’ box and follow the prompts Neurovascular Guidewires—
and/or go to the Dockets Management Performance Tests and Recommended DEPARTMENT OF HEALTH AND
Staff, 5630 Fishers Lane, Rm. 1061, Labeling.’’ It does not establish any HUMAN SERVICES
Rockville, MD 20852. rights for any person and is not binding
on FDA or the public. You can use an Food and Drug Administration
You may submit comments on any
guidance at any time (see 21 CFR alternative approach if it satisfies the [Docket No. FDA–2018–D–1861]
10.115(g)(5)). requirements of the applicable statutes
An electronic copy of the guidance and regulations. This guidance is not Hazard Analysis and Risk-Based
document is available for download subject to Executive Order 12866. Preventive Controls for Food for
from the internet. See the Animals: Supply-Chain Program; Draft
III. Electronic Access
SUPPLEMENTARY INFORMATION section for Guidance for Industry; Availability
Persons interested in obtaining a copy
information on electronic access to the AGENCY: Food and Drug Administration,
of the draft guidance may do so by
guidance. Submit written requests for a HHS.
downloading an electronic copy from
single hard copy of the draft guidance ACTION: Notice of availability.
the internet. A search capability for all
entitled ‘‘Coronary, Peripheral, and
Center for Devices and Radiological
Neurovascular Guidewires— SUMMARY: The Food and Drug
Health guidance documents is available
Performance Tests and Recommended Administration (FDA, we, or Agency) is
at https://www.fda.gov/MedicalDevices/
Labeling’’ to the Office of the Center announcing the availability of a draft
DeviceRegulationandGuidance/
Director, Guidance and Policy guidance for industry #246 entitled
GuidanceDocuments/default.htm. This
Development, Center for Devices and ‘‘Hazard Analysis and Risk-Based
draft guidance is also available at
Radiological Health, Food and Drug Preventive Controls for Food for
https://www.regulations.gov. Persons
Administration, 10903 New Hampshire Animals: Supply-Chain Program.’’ This
unable to download an electronic copy
Ave., Bldg. 66, Rm. 5431, Silver Spring, draft guidance document, when
of ‘‘Coronary, Peripheral, and
MD 20993–0002. Send one self- finalized, will help animal food
Neurovascular Guidewires—
addressed adhesive label to assist that facilities comply with the requirements
Performance Tests and Recommended
office in processing your request. for the supply-chain program under our
Labeling’’ may send an email request to
FOR FURTHER INFORMATION CONTACT: CDRH-Guidance@fda.hhs.gov to receive regulation ‘‘Current Good
Jismi Johnson, Center for Devices and an electronic copy of the document. Manufacturing Practice, Hazard
Radiological Health, Food and Drug Please use the document number 16007 Analysis, and Risk-Based Preventive
Administration, 10903 New Hampshire to identify the guidance you are Controls for Food for Animals.’’
Ave., Bldg. 66, Rm. 1524, Silver Spring, requesting. DATES: Submit either electronic or
MD 20993–0002, 301–796–6424. written comments on the draft guidance
SUPPLEMENTARY INFORMATION:
IV. Paperwork Reduction Act of 1995 by December 12, 2018 to ensure that the
This draft guidance refers to Agency considers your comment on this
I. Background previously approved collections of draft guidance before it begins work on
FDA is announcing the availability of information found in FDA regulations the final version of the guidance.
a draft guidance for industry and FDA and guidance. These collections of ADDRESSES: You may submit comments
staff entitled ‘‘Coronary, Peripheral, and information are subject to review by the on any guidance at any time as follows:
Neurovascular Guidewires— Office of Management and Budget
Performance Tests and Recommended (OMB) under the Paperwork Reduction Electronic Submissions
Labeling.’’ This draft guidance updates Act of 1995 (44 U.S.C. 3501–3520). The Submit electronic comments in the
and clarifies performance testing and collections of information in 21 CFR following way:
labeling recommendations to support a part 807, subpart E have been approved • Federal eRulemaking Portal:
premarket notification (510(k) under OMB control number 0910–0120; https://www.regulations.gov. Follow the
submission) for guidewires intended for the collections of information in 21 CFR instructions for submitting comments.
use in the coronary, peripheral, and part 820 have been approved under Comments submitted electronically,
sradovich on DSK3GMQ082PROD with NOTICES
neurovasculature. This draft guidance is OMB control number 0910–0073; the including attachments, to https://
intended to assist industry in designing collections of information in 21 CFR www.regulations.gov will be posted to
and executing appropriate performance part 812 have been approved under the docket unchanged. Because your
testing to support a premarket OMB control number 0910–0078; the comment will be made public, you are
notification and provides collections of information in 21 CFR solely responsible for ensuring that your
recommendations for content and part 801 have been approved under comment does not include any
labeling to include in the submission. OMB control number 0910–0485; and confidential information that you or a
VerDate Sep<11>2014 17:11 Jun 14, 2018 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\15JNN1.SGM 15JNN1](https://thefederalregister.org/doc/83_FR_28114/page/2.svg)
Document Created: 2018-11-02 12:01:03
Document Modified: 2018-11-02 12:01:03
| 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 the draft guidance by August 14, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Jismi Johnson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993-0002, 301-796-6424. | |
| FR Citation | 83 FR 27998 |
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