[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
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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