Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability, 17838-17840 [2019-08466]
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17838
Federal Register / Vol. 84, No. 81 / Friday, April 26, 2019 / Notices
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Agreement for Shipment of Devices for
Sterilization—21 CFR 801.150
OMB Control Number 0910–0131—
Extension
Under sections 501(c) and 502(a) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 351(c) and
352(a)), nonsterile devices that are
labeled as sterile but are in interstate
transit to a facility to be sterilized are
adulterated and misbranded. FDA
regulations at § 801.150(e) (21 CFR
801.150(e)) establish a control
mechanism by which firms may
manufacture and label medical devices
as sterile at one establishment and ship
the devices in interstate commerce for
sterilization at another establishment, a
practice that facilitates the processing of
devices and is economically necessary
for some firms.
Under § 801.150(e)(1), manufacturers
and sterilizers may sign an agreement
containing the following: (1) Contact
information of the firms involved and
the identification of the signature
authority of the shipper and receiver, (2)
instructions for maintaining
accountability of the number of units in
each shipment, (3) acknowledgment that
the devices that are nonsterile are being
shipped for further processing, and (4)
specifications for sterilization
processing. This agreement allows the
manufacturer to ship misbranded
products to be sterilized without
initiating regulatory action and provides
FDA with a means to protect consumers
from use of nonsterile products. During
routine plant inspections, FDA normally
reviews agreements that must be kept
for 2 years after final shipment or
delivery of devices (§ 801.150(a)(2)).
The respondents to this collection of
information are device manufacturers
and contract sterilizers. FDA’s estimate
of the reporting burden is based on data
obtained from industry over the past
several years. It is estimated that each of
the firms subject to this requirement
prepares an average of 20 written
agreements each year. This estimate
varies greatly, from 1 to 100, because
some firms provide sterilization services
on a part-time basis for only one
customer, while others are large
facilities with many customers. The
average time required to prepare each
written agreement is estimated to be 4
hours. This estimate varies depending
on whether the agreement is the initial
agreement or an annual renewal, on the
format each firm elects to use, and on
the length of time required to reach
agreement. The estimate applies only to
those portions of the written agreement
that pertain to the requirements
imposed by this regulation. The written
agreement generally also includes
contractual agreements that are a usual
and customary business practice. The
recordkeeping requirements of
§ 801.150(a)(2) consist of making copies
and maintaining the records required
under the third-party disclosure section
of this collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total hours
Record retention, 801.150(a)(2) ............................................................................
100
20
2,000
.5
1,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity/21 CFR section
Number of
respondents
Number of
disclosures
per
respondent
Total
annual
disclosures
Average
burden per
disclosure
Total hours
Agreement and labeling requirements, 801.150(e) ..............................................
100
20
2,000
4
8,000
amozie on DSK9F9SC42PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 900 total hours and
a corresponding increase of 400 records/
disclosures. We attribute this increase to
an increase in the number of agreements
that we have seen in inspection data
received over the last few years.
Dated: April 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–08470 Filed 4–25–19; 8:45 am]
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:
BILLING CODE 4164–01–P
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
17:28 Apr 25, 2019
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ACTION:
Notice of availability.
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
SUMMARY:
E:\FR\FM\26APN1.SGM
26APN1
Federal Register / Vol. 84, No. 81 / Friday, April 26, 2019 / Notices
(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’’).
amozie on DSK9F9SC42PROD with NOTICES
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
VerDate Sep<11>2014
17:28 Apr 25, 2019
Jkt 247001
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/201523389.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
PO 00000
Frm 00068
Fmt 4703
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17839
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 selfaddressed 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. Nonclinical 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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Federal Register / Vol. 84, No. 81 / Friday, April 26, 2019 / Notices
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
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 CDRH-Guidance@fda.hhs.gov
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:
21 CFR part; guidance; or FDA form
Topic
807, subpart E ..............................................................................................................
814, subparts A through E ...........................................................................................
814, subpart H ..............................................................................................................
812 ................................................................................................................................
‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)‘‘ ...
Premarket notification ...............................
Premarket approval ..................................
Humanitarian Device Exemption ..............
Investigational Device Exemption .............
De Novo classification process ................
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program: List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
the Public Health Service (PHS) Act.
While the Secretary of Health and
Human Services is named as the
respondent in all proceedings brought
by the filing of petitions for
compensation under the Program, the
United States Court of Federal Claims is
charged by statute with responsibility
for considering and acting upon the
petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
SUMMARY:
amozie on DSK9F9SC42PROD with NOTICES
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.
VerDate Sep<11>2014
17:28 Apr 25, 2019
Jkt 247001
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 08N146B,
Rockville, MD 20857; (301) 443–6593,
or visit our website at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of HHS, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
PO 00000
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OMB control
No.
0910–0120
0910–0231
0910–0332
0910–0078
0910–0844
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
March 1, 2019, through March 31, 2019.
This list provides the name of
petitioner, city and state of vaccination
(if unknown then city and state of
person or attorney filing claim), and
case number. In cases where the Court
has redacted the name of a petitioner
and/or the case number, the list reflects
such redaction.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
------------------------------------------------------------------------
OMB control
21 CFR part; guidance; or FDA form Topic No.
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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
