80 FR 49244 - Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices; 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 158 (August 17, 2015)

The Food and Drug Administration (FDA) is announcing the availability of the 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 to mitigate future outbreaks of TASS.

[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Page 49244]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20229]



[[Page 49244]]

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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; 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 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 to mitigate 
future outbreaks of TASS.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

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 a single hard copy of the 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 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 over the past decade from 
approximately 1 in 1,000 to about 2 in 100. Some cases of TASS are 
severe enough to require secondary surgical interventions including 
glaucoma surgery and corneal transplantation. 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.
    The draft of this guidance was made available in the Federal 
Register on April 17, 2014 (79 FR 21777), and the comment period closed 
July 16, 2014. Only two sets of comments were received. The comments 
were minor, and FDA made revisions to the document in response to the 
comments where appropriate. FDA also removed posterior segment devices 
from the scope of the guidance document. FDA may address endotoxin 
testing recommendations for this device type in future guidance 
documents.

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 endotoxin testing and limits for single-use 
IODs. 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.

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 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 ``Endotoxin Testing 
Recommendations for Single-Use Intraocular Ophthalmic Devices'' may 
send an email request to [email protected] to receive an 
electronic copy of the document. Please use the document number 1836 to 
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This 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: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20229 Filed 8-14-15; 8:45 am]
 BILLING CODE 4164-01-P