80 FR 39440 - Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 131 (July 9, 2015)

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.'' This draft guidance describes FDA's intent to address the safety concerns by clarifying new expectations for labeling with regard to the soon-to-be revised heparin United States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 This draft guidance is not final nor is it in effect at this time.

[Federal Register Volume 80, Number 131 (Thursday, July 9, 2015)]
[Notices]
[Pages 39440-39441]
From the Federal Register Online  [www.thefederalregister.org]
[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Recommendations for Labeling and Safety Testing; Draft Guidance for 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availability of the draft guidance entitled ``Heparin-Containing 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 This draft guidance describes FDA's intent to 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 This draft guidance is not final nor is it in effect 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 7, 2015.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