
[Federal Register Volume 79, Number 74 (Thursday, April 17, 2014)]
[Notices]
[Pages 21777-21778]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08711]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0332]


Endotoxin Testing Recommendations for Single-Use Intraocular 
Ophthalmic Devices; Draft Guidance for Industry and Food and Drug 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availability of the draft guidance entitled ``Endotoxin Testing 
Recommendations for Single-Use Intraocular Ophthalmic Devices.'' 
National outbreaks of Toxic Anterior Segment Syndrome (TASS) have been 
associated with single-use intraocular ophthalmic devices (IODs) and 
single-use intraocular ophthalmic surgical instruments/accessories that 
are contaminated with endotoxins. These devices can become contaminated 
as part of the manufacturing, sterilization, or packaging processes. 
This guidance document provides recommendations for endotoxin limits as 
well as endotoxin testing to manufacturers and other entities involved 
in submitting premarket applications (PMAs) or premarket notification 
submissions (510(k)s) for different categories of IODs

[[Page 21778]]

to mitigate future outbreaks of TASS. This draft guidance is not final 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 16, 2014.

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requests for single copies of the draft guidance document entitled 
``Endotoxin Testing Recommendations for Single-Use Intraocular 
Ophthalmic Devices'' 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: Michelle Tarver, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2504, Silver Spring, MD 20993-0002, 301-
796-5620.

SUPPLEMENTARY INFORMATION:

I. Background

    TASS has been increasing in frequency. Some cases of TASS are 
severe enough to require secondary surgical interventions including 
glaucoma surgery and corneal transplantation. It is estimated that 
clusters of 3 to 20 cases of TASS occur several times each year, 
translating to an estimated incidence of more than 1 in 1,000. The use 
of inadequately or improperly processed ophthalmic surgical instruments 
is one of many factors suggested as a potential cause of TASS. In many 
TASS cases, bacterial endotoxin from medical devices is believed to 
cause the inflammation.
    This guidance document was developed to notify manufacturers and 
other entities involved in submitting PMAs or 510(k)s for different 
categories of IODs of the recommended endotoxin limit for the release 
of IODs and single-use intraocular ophthalmic surgical instruments/
accessories in an effort to mitigate future TASS outbreaks.

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 Agency's current thinking on endotoxin 
testing and limits for single-use IODs. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach 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 using the Internet. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov.
    To receive ``Endotoxin Testing Recommendations for Single-Use 
Intraocular Ophthalmic Devices,'' you may either send an email request 
to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the 
document or send a fax request to 301-847-8149 to receive a hard copy. 
Please use the document number 1836 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 814 have been approved under 
OMB control number 0910-0231.

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: April 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08711 Filed 4-16-14; 8:45 am]
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