[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Notices]
[Pages 27996-27998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12824]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1788]


Intravascular Catheters, Wires, and Delivery Systems With 
Lubricious Coatings--Labeling Considerations; Draft Guidance for 
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 27997]]


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the availability of the draft guidance entitled ``Intravascular 
Catheters, Wires, and Delivery Systems with Lubricious Coatings--
Labeling Considerations.'' This draft guidance addresses labeling 
considerations for devices containing lubricious coatings that are used 
in the vasculature. The purpose of this draft guidance is to provide 
recommendations for information to be included in device labeling, as 
submitted in premarket applications (PMAs) or premarket notification 
submissions (510(k)s) for class III and class II devices, to enhance 
the consistency of information across these product areas as well as to 
promote the safe use of these devices in clinical settings. This draft 
guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by August 14, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-1788 for ``Intravascular Catheters, Wires, and Delivery 
Systems with Lubricious Coatings--Labeling Considerations.'' 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.
    <bullet> 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 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.gpo.gov/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 draft 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 
``Intravascular Catheters, Wires, and Delivery Systems with Lubricious 
Coatings--Labeling Considerations'' 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: Leigh Anderson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 301-796-5613.

SUPPLEMENTARY INFORMATION: 

I. Background

    Hydrophilic- and/or hydrophobic-coated devices have been used for 
more than 20 years in minimally invasive diagnostic and therapeutic 
cerebrovascular, cardiovascular, and peripheral vascular procedures. 
Although these devices may offer patient benefits, evidence indicates 
that the coating may separate from intravascular devices in some 
circumstances. FDA has received and analyzed information concerning 
serious adverse events associated with hydrophilic and/or hydrophobic 
coatings separating (e.g., peeling, flaking, shedding, delaminating, or 
sloughing off) from intravascular medical devices.
    FDA has not concluded that any specific manufacturer or brand of 
these devices is associated with higher risks than others. The cause of 
coating separation is multifactorial, and can be associated with 
factors including device design, manufacturing, and use. Current FDA 
analysis suggests that use-related issues may be mitigated through 
proper device selection, preparation, and other labeling considerations 
that are addressed within this draft guidance.
    This draft guidance addresses labeling considerations for devices 
containing lubricious coatings used in the vasculature. The purpose of 
this draft

[[Page 27998]]

guidance is to provide recommendations for information to be included 
in device labeling, as submitted in PMAs or 510(k)s for class III and 
class II devices, to enhance the consistency of coating information 
across these product areas as well as to promote the safe use of these 
devices in clinical settings.

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 
``Intravascular Catheters, Wires, and Delivery Systems with Lubricious 
Coatings--Labeling Considerations.'' 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 document is also available at https://www.regulations.gov. 
Persons unable to download an electronic copy of ``Intravascular 
Catheters, Wires, and Delivery Systems with Lubricious Coatings--
Labeling Considerations'' may send an email request to <a href="/cdn-cgi/l/email-protection#e3a0a7b1abcea4968a87828d8086a3858782cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="5b181f0913761c2e323f3a35383e1b3d3f3a75333328753c342d">[email protected]</span></a> to receive an electronic copy of the document. 
Please use the document number 16016 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 814, subparts A through E have been approved 
under OMB control number 0910-0231; and the collections of information 
in 21 CFR part 801 have been approved under OMB control number 0910-
0485.

    Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12824 Filed 6-14-18; 8:45 am]
BILLING CODE 4164-01-P


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