[Federal Register Volume 84, Number 81 (Friday, April 26, 2019)]
[Notices]
[Pages 17838-17840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08466]


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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 Non-Clinical Bench Performance 
Testing Information in Premarket Submissions; 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 ``Recommended Content and 
Format of Non-Clinical Bench Performance Testing Information in 
Premarket Submissions.'' FDA has developed this document to describe 
relevant information that should be included in test report summaries, 
test protocols, and complete test reports for non-clinical bench 
performance testing provided in a premarket submission

[[Page 17839]]

(i.e., premarket approval (PMA) applications, humanitarian device 
exemption (HDE) applications, premarket notification (510(k)) 
submissions, investigational device exemption (IDE) applications, and 
De Novo requests).

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, 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 Non-Clinical 
Bench Performance Testing Information 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)).
    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 
``Recommended Content and Format of Non-Clinical Bench Performance 
Testing Information in Premarket Submissions'' 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: Jismi Johnson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993-0002, 301-796-6424.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of the guidance for industry and 
FDA staff entitled ``Recommended Content and Format of Non-Clinical 
Bench Performance Testing Information in Premarket Submissions.'' FDA 
has developed this document to describe relevant information that 
should be included in test report summaries, test protocols, and 
complete test reports for non-clinical bench performance testing 
provided in a premarket submission (i.e., PMA, HDE applications, 510(k) 
submissions, IDE applications, and De Novo requests).
    Non-clinical bench performance testing is defined as performance 
testing, performed by either a device manufacturer or a third-party 
testing facility (e.g., test laboratory), which 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, burst pressure); bench 
tests using ex vivo, in vitro, and in situ animal or human tissue; and 
animal carcass or human cadaveric testing.
    Non-clinical bench performance testing excludes biocompatibility 
evaluation, reprocessing or sterilization validation, human factors, 
software verification and validation, and computational modeling 
because relevant information on these assessments are included in 
associated guidance documents. Test reports for clinical studies, 
animal studies, and studies evaluating the performance characteristics 
of in vitro diagnostic devices are also excluded from the scope of this 
document.
    This 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 guidance is 
intended

[[Page 17840]]

to be used in conjunction with other FDA guidance documents, including 
device-specific guidances, as well as in conjunction with specific test 
reporting recommendations in FDA-recognized standards.
    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of May 31, 2018 (83 FR 25014). 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 recommended content and format of non-
clinical bench performance testing information 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 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 Non-Clinical Bench Performance Testing Information 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 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:

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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.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)``.                 process.
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    Dated: April 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08466 Filed 4-25-19; 8:45 am]
 BILLING CODE 4164-01-P


