Document ID: FDA-2008-D-0611-0016
Agency: fda
Document Type: Notice
Title: Submission and Review of Sterility Information in Premarket Notification
(510(k)) Submissions for Devices Labeled as Sterile; Guidance for
Industry and Food and Drug Administration Staff; Availability
Posted Date: 2016-01-21T05:00Z

[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3436-3438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01093]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0611]

Submission and Review of Sterility Information in Premarket 
Notification (510(k)) Submissions for Devices Labeled as Sterile; 
Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Submission and Review of 
Sterility Information in Premarket Notification (510(k)) Submissions 
for Devices Labeled as Sterile.'' This guidance updates and clarifies 
the information regarding sterilization processes that FDA recommends 
sponsors include in 510(k)s for devices labeled as sterile. This 
guidance document also provides details about the pyrogenicity 
information that FDA recommends sponsors include in a 510(k) 
submission.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time. The recommendations in this guidance will be implemented on 
March 21, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:

[[Page 3437]]

     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2008-D-0611 for ``Submission and Review of Sterility Information in 
Premarket Notification (510(k)) Submissions for Devices Labeled as 
Sterile; Guidance for Industry and Food and Drug Administration Staff; 
Availability.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 
``Submission and Review of Sterility Information in Premarket 
Notification (510(k)) Submissions for Devices Labeled as Sterile'' 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.
    Alternatively, you may submit written requests for single copies of 
the guidance document to the Office of Communication, Outreach and 
Development, Center for Biologics Evaluation and Research (CBER), Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your request. The guidance may also be 
obtained by mail by calling CBER at 1-800-835-4709 or 240-402-8010.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527; 
or Stephen Ripley, Center for Biologics Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, 
Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, FDA has received an increasing number of 510(k)s 
for devices labeled as sterile that are sterilized during the 
manufacturing process by methods other than the traditionally used 
methods (i.e., steam, dry heat, ethylene oxide (EO), and radiation). 
FDA has experience with some of the other methods and now considers 
them to be established methods. However, there may be alterations to 
the more recently developed methods. In addition, original, innovative 
sterilization technologies are being developed and proposed. FDA 
considers these to be novel methods, which carry a substantial risk of 
inadequate sterility assurance. Consequently, devices sterilized using 
these technologies may not comply with Good Manufacturing Practice. 
Failure to assure sterility presents a serious risk to human health 
because of the risk of infection. Therefore, we intend to inspect the 
manufacturing facility before clearing a 510(k) for a device that is 
sterilized by a novel sterilization process. We believe inspecting the 
manufacturing facility for devices sterilized using these novel 
sterilization technologies will help ensure the safety and 
effectiveness of these devices and mitigate the risks to human health.
    This guidance document updates and clarifies the information 
regarding sterilization processes that we recommend sponsors include in 
510(k)s for devices labeled as sterile. This guidance document also 
provides details about the pyrogenicity information that we recommend 
sponsors include in a 510(k) submission. In the Federal Register of 
December 12, 2008 (73 FR 75724), FDA announced the availability of the 
draft of this guidance. Interested persons were invited to comment by 
March 12, 2009. FDA considered the public comments received and revised 
the guidance, where applicable. This

[[Page 3438]]

document supersedes ``Updated 510(k) Sterility Review Guidance K90-1'' 
dated August 30, 2002.

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 submission and review of sterility 
information in 510(k)s for devices labeled as sterile. 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.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to 
download an electronic copy of ``Submission and Review of Sterility 
Information in Premarket Notification (510(k)) Submissions for Devices 
Labeled as Sterile'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 1615 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 807, subpart E, have been 
approved under OMB control number 0910-0120; and the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073.

    Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01093 Filed 1-20-16; 8:45 am]
 BILLING CODE 4164-01-P