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