[Federal Register Volume 83, Number 105 (Thursday, May 31, 2018)]
[Notices]
[Pages 25014-25015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11603]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1329]


Recommended Content and Format of Complete Test Reports for Non-
Clinical Bench Performance Testing in Premarket Submissions; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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the availability of the draft guidance entitled ``Recommended Content 
and Format of Complete Test Reports for Non-Clinical Bench Performance 
Testing in Premarket Submissions.'' FDA has developed this document to 
describe relevant information that should be included in complete test 
reports for non-clinical bench performance testing provided in a 
premarket submission (i.e., premarket approval (PMA) applications, 
humanitarian device exemption (HDE) applications, premarket 
notification (510(k)) submissions, investigational device exemption 
(IDE) applications, and De Novo classification requests). This draft 
guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by July 30, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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, 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-2018-D-1329 for ``Recommended Content and Format of Complete Test 
Reports for Non-Clinical Bench Performance Testing in Premarket 
Submissions.'' 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)).

[[Page 25015]]

    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 draft guidance document entitled 
``Recommended Content and Format of Complete Test Reports for Non-
Clinical Bench Performance Testing in Premarket Submissions'' 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.

FOR FURTHER INFORMATION CONTACT: Mary Wen, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1529, Silver Spring, MD 20993-0002, 240-402-4913.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled ``Recommended Content and Format of Complete 
Test Reports for Non-Clinical Bench Performance Testing in Premarket 
Submissions.'' FDA has developed this document to describe relevant 
information that should be included in complete test reports for non-
clinical bench performance testing provided in a premarket submission 
(i.e., PMA applications, HDE applications, 510(k) submissions, IDE 
applications, and De Novo classification requests).
    Non-clinical bench performance testing is defined as performance 
testing that encompasses all bench testing and will be dependent upon 
the specifics of the actual device or device type. Non-clinical bench 
performance testing includes, but is not limited to, mechanical and 
biological engineering performance such as fatigue, wear, tensile 
strength, compression, and burst pressure; bench tests using animal or 
human tissue; and animal carcass or human cadaveric testing. Non-
clinical bench performance testing excludes biocompatibility 
evaluation, sterilization, and animal in vivo evaluation.
    This draft guidance is intended to help ensure that clear and 
consistent information is provided in premarket submissions containing 
non-clinical bench performance testing. The information in this draft 
guidance is intended to be used in conjunction with other FDA guidance 
documents, including device-specific guidances.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Recommended 
Content and Format of Complete Test Reports for Non-Clinical Bench 
Performance Testing in Premarket Submissions.'' 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 draft 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 ``Recommended Content 
and Format of Complete Test Reports for Non-Clinical Bench Performance 
Testing in Premarket Submissions'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 18011 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This draft 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 the following FDA regulations and 
guidances have been approved by OMB as listed:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               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.
De Novo Classification Process      De Novo                    0910-0844
 (Evaluation of Automatic Class      Classification
 III Designation).                   process.
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    Dated: May 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11603 Filed 5-30-18; 8:45 am]
 BILLING CODE 4164-01-P


