[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Notices]
[Pages 54608-54609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22192]


=======================================================================
-----------------------------------------------------------------------

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; 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 a final guidance entitled ``Intravascular 
Catheters, Wires, and Delivery Systems with Lubricious Coatings-
Labeling Considerations.'' This guidance addresses labeling 
considerations for devices containing lubricious coatings used in the 
vasculature. The purpose of this guidance is to provide recommendations 
for information to be included in the 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 the clinical setting.

DATES: The announcement of the guidance is published in the Federal 
Register on October 10, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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-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.
     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 guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for

[[Page 54609]]

information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Intravascular Catheters, Wires, and Delivery Systems with Lubricious 
Coatings--Labeling Considerations'' to the Office of Policy, 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, 
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, device 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 guidance.
    This guidance addresses labeling considerations for devices 
containing lubricious coatings used in the vasculature. The purpose of 
this guidance is to provide recommendations for information to be 
included in the device labeling, as submitted in PMAs or premarket 
notification submissions (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 the 
clinical setting.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of June 15, 2018 (83 FR 27996). FDA 
revised the guidance as appropriate in response to the comments.

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 
current thinking of FDA on labeling considerations for intravascular 
catheters, wires, and delivery systems with lubricious coating. 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 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 
guidance 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 CDRH-Guidance@fda.hhs.gov 
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 guidance refers to previously approved collections of 
information. 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. 3501-3521). The collections of information in 
the following FDA regulations have been approved by OMB as listed in 
the following table:

------------------------------------------------------------------------
           21 CFR part                   Topic          OMB control No.
------------------------------------------------------------------------
807, subpart E..................  Premarket                    0910-0120
                                   Notification.
814, subparts A through E.......  Premarket Approval.          0910-0231
801.............................  Medical Device               0910-0485
                                   Labeling
                                   Regulations.
------------------------------------------------------------------------


    Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22192 Filed 10-9-19; 8:45 am]
 BILLING CODE 4164-01-P


