Document ID: FDA-2016-D-0363-0013
Agency: fda
Document Type: Notice
Title: Characterization of Ultrahigh Molecular Weight Polyethylene Used in Orthopedic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2019-04-26T04:00Z

[Federal Register Volume 84, Number 81 (Friday, April 26, 2019)]
[Notices]
[Pages 17832-17834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08465]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0363]

Characterization of Ultrahigh Molecular Weight Polyethylene Used 
in Orthopedic Devices; 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 a final guidance entitled ``Characterization of 
Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic 
Devices.'' The guidance identifies the types of UHMWPE commonly in use 
in orthopedic implants, as well as the recommended information and 
testing that should be included in premarket submissions for such 
devices.

DATES: The announcement of the guidance is published in the Federal 
Register on April 26, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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,

[[Page 17833]]

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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2016-D-0363 for ``Characterization of Ultrahigh Molecular Weight 
Polyethylene (UHMWPE) Used in Orthopedic Devices.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 
``Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) 
Used in Orthopedic Devices'' to the Office of Policy, 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.

FOR FURTHER INFORMATION CONTACT: Peter Allen, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1512, Silver Spring, MD 20993-0002, 301-796-6402.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry and 
FDA staff entitled ``Characterization of Ultrahigh Molecular Weight 
Polyethylene (UHMWPE) Used in Orthopedic Devices.'' FDA has developed 
this guidance document for members of industry who submit, and FDA 
staff who review, information regarding orthopedic devices using UHMWPE 
material. This guidance is intended to provide recommendations 
regarding the characterization and testing of orthopedic devices that 
use UHMWPE materials such as conventional UHMWPE, highly crosslinked 
UHMWPE, highly crosslinked UHMWPE containing antioxidants, and non-
conventional UHMWPE. This guidance also outlines the information FDA 
recommends industry include in a regulatory submission to characterize 
the UHMWPE material (e.g., material description, sterility, 
biocompatibility, mechanical properties, and chemical properties). FDA 
considered comments received on the draft guidance that appeared in the 
Federal Register of February 12, 2016 (81 FR 7543). FDA revised the 
guidance as appropriate in response to the comments.

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 the characterization of UHMWPE used in 
orthopedic devices. 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. This guidance is not subject to Executive Order 12866.

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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov. 
Persons unable to download an electronic copy of ``Characterization of 
Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic 
Devices'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number 1300006 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information. 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 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

[[Page 17834]]

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                                                            OMB control
21 CFR part; guidance; or FDA form          Topic               No.
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807, subpart E....................  Premarket                  0910-0120
                                     notification.
814, subparts A through E.........  Premarket approval..       0910-0231
814, subpart H....................  Humanitarian Device        0910-0332
                                     Exemption.
812...............................  Investigational            0910-0078
                                     Device Exemption.
820...............................  Quality System             0910-0073
                                     Regulation.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)''.                 process.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
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    Dated: April 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08465 Filed 4-25-19; 8:45 am]
 BILLING CODE 4164-01-P