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)
Food and Drug Administration
Federal Register Volume 80, Issue 158 (August 17, 2015)
| Page Range | 49244-49244 | |
| FR Document | 2015-20229 |
[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]] ----------------------------------------------------------------------- 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
![49244 Federal Register / Vol. 80, No. 158 / Monday, August 17, 2015 / Notices
DEPARTMENT OF HEALTH AND 5630 Fishers Lane, Rm. 1061, Rockville, Center for Devices and Radiological
HUMAN SERVICES MD 20852. Identify comments with the Health guidance documents is available
docket number found in brackets in the at http://www.fda.gov/MedicalDevices/
Food and Drug Administration heading of this document. DeviceRegulationandGuidance/
FOR FURTHER INFORMATION CONTACT: GuidanceDocuments/default.htm.
[Docket No. FDA–2014–D–0332]
Michelle Tarver, Center for Devices and Guidance documents are also available
Endotoxin Testing Recommendations Radiological Health, Food and Drug at http://www.regulations.gov. Persons
for Single-Use Intraocular Ophthalmic Administration, 10903 New Hampshire unable to download an electronic copy
Devices; Guidance for Industry and Ave., Bldg. 66, Rm. 2504, Silver Spring, of ‘‘Endotoxin Testing
Food and Drug Administration Staff; MD 20993–0002, 301–796–5620. Recommendations for Single-Use
Availability SUPPLEMENTARY INFORMATION: Intraocular Ophthalmic Devices’’ may
send an email request to CDRH-
AGENCY: Food and Drug Administration, I. Background Guidance@fda.hhs.gov to receive an
HHS. TASS has been increasing in electronic copy of the document. Please
ACTION: Notice. frequency over the past decade from use the document number 1836 to
approximately 1 in 1,000 to about 2 in identify the guidance you are
SUMMARY: The Food and Drug 100. Some cases of TASS are severe requesting.
Administration (FDA) is announcing the enough to require secondary surgical
availability of the guidance entitled interventions including glaucoma IV. Paperwork Reduction Act of 1995
‘‘Endotoxin Testing Recommendations surgery and corneal transplantation. The This guidance refers to previously
for Single-Use Intraocular Ophthalmic use of inadequately or improperly approved collections of information
Devices.’’ National outbreaks of Toxic processed ophthalmic surgical found in FDA regulations. These
Anterior Segment Syndrome (TASS) instruments is one of many factors collections of information are subject to
have been associated with single-use suggested as a potential cause of TASS. review by the Office of Management and
intraocular ophthalmic devices (IODs) In many TASS cases, bacterial Budget (OMB) under the Paperwork
and single-use intraocular ophthalmic endotoxin from medical devices is Reduction Act of 1995 (44 U.S.C. 3501–
surgical instruments/accessories that are believed to cause the inflammation. 3520). The collections of information in
contaminated with endotoxins. These This guidance document was 21 CFR part 814 have been approved
devices can become contaminated as developed to notify manufacturers and under OMB control number 0910–0231.
part of the manufacturing, sterilization, other entities involved in submitting
or packaging processes. This guidance PMAs or 510(k)s for different categories V. Comments
document provides recommendations of IODs of the recommended endotoxin Interested persons may submit either
for endotoxin limits as well as limit for the release of IODs and single- electronic comments regarding this
endotoxin testing to manufacturers and use intraocular ophthalmic surgical document to http://www.regulations.gov
other entities involved in submitting instruments/accessories in an effort to or written comments to the Division of
premarket applications (PMAs) or mitigate future TASS outbreaks. Dockets Management (see ADDRESSES). It
premarket notification submissions The draft of this guidance was made is only necessary to send one set of
(510(k)s) for different categories of IODs available in the Federal Register on comments. Identify comments with the
to mitigate future outbreaks of TASS. April 17, 2014 (79 FR 21777), and the docket number found in brackets in the
DATES: Submit either electronic or
comment period closed July 16, 2014. heading of this document. Received
written comments on this guidance at Only two sets of comments were comments may be seen in the Division
any time. General comments on Agency received. The comments were minor, of Dockets Management between 9 a.m.
guidance documents are welcome at any and FDA made revisions to the and 4 p.m., Monday through Friday, and
time. document in response to the comments will be posted to the docket at http://
where appropriate. FDA also removed www.regulations.gov.
ADDRESSES: An electronic copy of the
posterior segment devices from the
guidance document is available for Dated: August 12, 2015.
scope of the guidance document. FDA
download from the Internet. See the may address endotoxin testing Leslie Kux,
SUPPLEMENTARY INFORMATION section for Associate Commissioner for Policy.
recommendations for this device type in
information on electronic access to the future guidance documents. [FR Doc. 2015–20229 Filed 8–14–15; 8:45 am]
guidance. Submit written requests for a BILLING CODE 4164–01–P
single hard copy of the guidance II. Significance of Guidance
document entitled ‘‘Endotoxin Testing This guidance is being issued
Recommendations for Single-Use consistent with FDA’s good guidance DEPARTMENT OF HEALTH AND
Intraocular Ophthalmic Devices’’ to the practices regulation (21 CFR 10.115). HUMAN SERVICES
Office of the Center Director, Guidance The guidance represents the current
and Policy Development, Center for thinking of FDA on endotoxin testing Food and Drug Administration
Devices and Radiological Health, Food and limits for single-use IODs. It does
and Drug Administration, 10903 New not establish any rights for any person [Docket No. FDA–2015–D–2843]
Hampshire Ave., Bldg. 66, rm. 5431, and is not binding on FDA or the public.
Silver Spring, MD 20993–0002. Send Qualification of Biomarker—Total
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assist that office in processing your Treatment of Autosomal Dominant
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request. Polycystic Kidney Disease; Draft
Submit electronic comments on the III. Electronic Access Guidance for Industry; Availability
guidance to http://www.regulations.gov. Persons interested in obtaining a copy AGENCY: Food and Drug Administration,
Submit written comments to the of the guidance may do so by HHS.
Division of Dockets Management (HFA– downloading an electronic copy from
ACTION: Notice.
305), Food and Drug Administration, the Internet. A search capability for all
VerDate Sep<11>2014 16:57 Aug 14, 2015 Jkt 235001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\17AUN1.SGM 17AUN1](https://thefederalregister.org/doc/80_FR_49402/page/1.svg)
Document Created: 2015-12-15 11:07:21
Document Modified: 2015-12-15 11:07:21
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| 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. | |
| FR Citation | 80 FR 49244 |
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