[Federal Register Volume 80, Number 131 (Thursday, July 9, 2015)]
[Notices]
[Pages 39440-39441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-16775]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-2167]
Heparin-Containing Medical Devices and Combination Products:
Recommendations for Labeling and Safety Testing; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Heparin-Containing
Medical Devices and Combination Products: Recommendations for Labeling
and Safety Testing.'' This draft guidance describes FDA's intent to
address the safety concerns by clarifying new expectations for labeling
with regard to the soon-to-be revised heparin United States
Pharmacopeia (USP) monographs as well as outline safety testing
recommendations. This draft guidance is not final nor is it in effect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 on 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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 7, 2015.
ADDRESSES: 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requests for single copies of the draft guidance document entitled
``Heparin-Containing Medical Devices and Combination Products:
Recommendations for Labeling and Safety Testing'' 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.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Angela Krueger, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301-796-6380.
SUPPLEMENTARY INFORMATION:
I. Background
The USP \1\ heparin monographs have recently undergone several
revisions following serious and fatal events related to the use of
heparin sodium products. Investigation of heparin product overdose
errors identified the expression of drug strength in the labels as a
major contributing factor in these errors. This draft guidance document
is intended to address these safety concerns by clarifying new
expectations for labeling with regard to the soon-to-be revised heparin
USP monographs (USP36-NF31),\2\ as well as outline safety testing
recommendations.
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\1\ USP is a scientific nonprofit organization that develops
standards for the identity, strength, quality, and purity of drugs
and drug ingredients marketed in the United States. These standards
are published in USP's official compendia, ``United States
Pharmacopeia and National Formulary.''
\2\ USP monograph, USP PF 38 (3) and (5) Interim Revision
Announcement, with proposed effective revision date of May 1, 2013.
See also ``FDA Drug Safety Communication: Important Change to
Heparin Container Labels to Clearly State the Total Drug Strength''
at http://www.fda.gov/Drugs/DrugSafety/ucm330695.htm.
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In addition, the outbreak of serious and often fatal events due to
heparin contamination with over-sulfated chondroitin sulfate in 2008
led the USP to include in its monograph additional testing of heparin
source material to ensure its quality and purity. This draft guidance
also outlines use of conformance to the monograph in premarket
submissions, specifically testing and documentation requirements and
recommendations contained in the current USP monograph, and the
guidance document ``Heparin for Drug and Medical Device Use: Monitoring
Crude Heparin for Quality'' (http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatory
[[Page 39441]]
Information/Guidances/UCM291390.pdf).\3\
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\3\ The Agency updates guidances periodically. To make sure you
have the most recent version of this guidance, check the CDER
guidance page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
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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 labeling and
safety testing requirements for heparin-containing medical devices and
combination products. 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 statute 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 Device and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Heparin-Containing Medical
Devices and Combination Products: Recommendations for Labeling and
Safety Testing'' may send an email request to [email protected]
to receive an electronic copy of the document. Please use the document
number 1817 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently 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 211 (Current Good
Manufacturing Practice for Finished Pharmaceuticals) have been approved
under OMB control number 0910-0139. The collections of information in
FDA's medical devices regulations in 21 CFR parts 801 (Labeling); 803
(Medical Device Reporting); 807, subpart E (Premarket Notification
Procedures); 812 (Investigational Device Exemptions); 814, subparts A
through E (Premarket Approval of Medical Devices); 814, subpart H
(Humanitarian Use Devices); and 820 (Quality System Regulation) have
been approved under OMB control numbers 0910-0485, 0910-0437, 0910-
0120, 0910-0078, 0910-0231, 0910-0332, and 0910-0073 respectively.
V. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
Dated: July 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16775 Filed 7-8-15; 8:45 am]
BILLING CODE 4164-01-P