[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Page 49244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20229]
[[Page 49244]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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