Qualification of Medical Device Development Tools; Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability, 37456-37458 [2017-16827]
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Federal Register / Vol. 82, No. 153 / Thursday, August 10, 2017 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Total number
of respondents
Instrument
Follow-up classroom observation protocol (teacher burden) ..................................................................................
Follow-up protocol for child assessments in Impact Evaluation only (child burden) .................................................
Annual
number of
respondents
Number of
responses per
respondent
Average
burden
hours per
response
Annual burden
hours
543
181
2
0.30
109
1980
660
1
1
660
Fidelity of Implementation Instruments for Pilot Study and Process Study
mstockstill on DSK30JT082PROD with NOTICES
Coach Log ............................................................................
Teacher/assistant teacher Log ............................................
Implementation fidelity observation protocol (teacher burden) ..................................................................................
Interview/Focus group protocol (administrator, teacher/assistant teacher and coach burden) ..................................
Estimated Total Annual Burden
Hours: 7,289.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW.,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. Email
address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2017–16854 Filed 8–9–17; 8:45 am]
BILLING CODE 4184–23–P
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39
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55
36
0.25
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3258
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1
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7
322
107
1
1.5
161
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1279]
Qualification of Medical Device
Development Tools; Guidance for
Industry, Tool Developers, and Food
and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the
guidance entitled ‘‘Qualification of
Medical Device Development Tools
(MDDT).’’ This document formalizes the
MDDT program and provides guidance
to FDA staff, industry, healthcare
providers, researchers, and patient and
consumer groups on a new voluntary
process within the Center for Devices
and Radiological Health (CDRH) for
qualification of medical device
development tools (MDDT) for use in
device development and evaluation
programs. In addition, the guidance
discusses the framework of an MDDT,
including definitions of applicable
terms, criteria for evaluating an MDDT
for a specific context of use,
considerations for qualification, and the
contents of a qualification package. FDA
considered comments on the draft
guidance and revised the guidance as
appropriate.
SUMMARY:
Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: You may submit comments
as follows:
DATES:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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.’’
E:\FR\FM\10AUN1.SGM
10AUN1
mstockstill on DSK30JT082PROD with NOTICES
Federal Register / Vol. 82, No. 153 / Thursday, August 10, 2017 / Notices
Instructions: All submissions received
must include the Docket No. FDA–
2013–D–1279 for ‘‘Qualification of
Medical Device Development Tools.’’
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/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.
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 ‘‘Qualification of
Medical Device Development Tools’’ to
the Office of the Center Director,
VerDate Sep<11>2014
17:03 Aug 09, 2017
Jkt 241001
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:
Kathryn O’Callaghan, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5418, Silver Spring,
MD 20993–0002, (301) 796–6349.
SUPPLEMENTARY INFORMATION:
I. Background
MDDT is a scientifically validated
tool that aids device development and
regulatory evaluation. The guidance
describes the framework and process for
the voluntary CDRH qualification of
MDDT, including definitions of
applicable terms, criteria for evaluating
a MDDT for a specific context of use, the
threshold for qualification, and the
contents of a qualification submission.
The intent of this voluntary
qualification policy is to: (1) Enable
faster, more efficient development of
important life-saving and health
promoting medical devices, (2) promote
the development of tools to facilitate
more timely device evaluation, (3)
provide a mechanism to better leverage
advances in regulatory science, and (4)
more quickly and more clearly
communicate with CDRH stakeholders
about important advances in regulatory
science that may be leveraged to speed
device development and regulatory
evaluation. CDRH expects the
qualification process to expedite
development of publicly available tools,
which could potentially be used widely
in multiple device development
programs.
The intent of this voluntary MDDT
program is to promote the development
and use of tools to streamline device
development and evaluation. Once an
MDDT is submitted in accordance with
the FDA guidance entitled ‘‘Requests for
Feedback on Medical Device
Submissions: The Pre-Submission
Program and Meetings with Food and
Drug Administration Staff’’ (Ref. 1) and
qualified for a specific context of use, it
can be used by any medical device
sponsor for that context of use. MDDTs
can be used for the qualified context of
use without the need to reconfirm the
suitability and utility of the MDDT
when used in a premarket submission.
Qualification may contribute to
acceptance and application of MDDTs
across multiple medical device
development programs. Qualified
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
37457
MDDTs can be utilized by many
sponsors to aid in optimizing device
development and evaluation.
As discussed in the November 14,
2013, Federal Register notice (78 FR
68459), FDA announced the availability
of the draft of this guidance and
interested persons were invited to
comment by February 12, 2014. In the
August 15, 2014, Federal Register
notice (79 FR 48170), FDA began
accepting nominations for participation
in the voluntary MDDT Pilot Program.
FDA reviewed and considered all public
comments received and revised this
guidance as appropriate.
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 ‘‘Qualification of
Medical Device Development Tools.’’ 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.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Qualification of Medical Device
Development Tools’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 1882 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance contains information
collection that is 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 under the
guidance entitled ‘‘Requests for
Feedback on Medical Device
Submissions: The Pre-Submission
Program and Meetings with Food and
Drug Administration Staff’’ have been
approved under OMB control number
0910–0756.
E:\FR\FM\10AUN1.SGM
10AUN1
37458
Federal Register / Vol. 82, No. 153 / Thursday, August 10, 2017 / Notices
V. Reference
The following reference is on display
in the Dockets Management Staff (see
ADDRESSES) and is available for viewing
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday; it
is also available electronically at https://
www.regulations.gov. FDA has verified
the Web site address, as of the date this
document publishes in the Federal
Register, but Web sites are subject to
change over time.
1. FDA Guidance, ‘‘Requests for Feedback on
Medical Device Submissions: The PreSubmission Program and Meetings with
Food and Drug Administration Staff.’’
Available at https://www.fda.gov/
downloads/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM311176.pdf.
Dated: August 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–16827 Filed 8–9–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Electronic Submissions
Food and Drug Administration
[Docket No. FDA–2017–N–1957]
Medical Imaging Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or the Agency)
announces a forthcoming public
advisory committee meeting of the
Medical Imaging Drugs Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public. FDA is
establishing a docket for public
comment on this document.
DATES: The public meeting will be held
on September 8, 2017, from 8 a.m. to 4
p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
mstockstill on DSK30JT082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:03 Aug 09, 2017
Jkt 241001
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2017–N–1957.
The docket will close on September 7,
2017. Submit either electronic or
written comments on this public
meeting by September 7, 2017.
Comments received on or before
August 24, 2017, will be provided to the
committee. Comments received after
that date will be taken into
consideration by the Agency.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before September 7, 2017. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of September 7, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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–
2017–N–1957 for ‘‘Medical Imaging
Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public
Docket; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), 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
E:\FR\FM\10AUN1.SGM
10AUN1
]]>Agencies
[Federal Register Volume 82, Number 153 (Thursday, August 10, 2017)]
[Notices]
[Pages 37456-37458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16827]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1279]
Qualification of Medical Device Development Tools; Guidance for
Industry, Tool Developers, and Food and Drug Administration Staff;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Qualification of Medical
Device Development Tools (MDDT).'' This document formalizes the MDDT
program and provides guidance to FDA staff, industry, healthcare
providers, researchers, and patient and consumer groups on a new
voluntary process within the Center for Devices and Radiological Health
(CDRH) for qualification of medical device development tools (MDDT) for
use in device development and evaluation programs. In addition, the
guidance discusses the framework of an MDDT, including definitions of
applicable terms, criteria for evaluating an MDDT for a specific
context of use, considerations for qualification, and the contents of a
qualification package. FDA considered comments on the draft guidance
and revised the guidance as appropriate.
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: You may submit comments 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.''
[[Page 37457]]
Instructions: All submissions received must include the Docket No.
FDA-2013-D-1279 for ``Qualification of Medical Device Development
Tools.'' 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.
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
``Qualification of Medical Device Development Tools'' 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: Kathryn O'Callaghan, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5418, Silver Spring, MD 20993-0002,
(301) 796-6349.
SUPPLEMENTARY INFORMATION:
I. Background
MDDT is a scientifically validated tool that aids device
development and regulatory evaluation. The guidance describes the
framework and process for the voluntary CDRH qualification of MDDT,
including definitions of applicable terms, criteria for evaluating a
MDDT for a specific context of use, the threshold for qualification,
and the contents of a qualification submission.
The intent of this voluntary qualification policy is to: (1) Enable
faster, more efficient development of important life-saving and health
promoting medical devices, (2) promote the development of tools to
facilitate more timely device evaluation, (3) provide a mechanism to
better leverage advances in regulatory science, and (4) more quickly
and more clearly communicate with CDRH stakeholders about important
advances in regulatory science that may be leveraged to speed device
development and regulatory evaluation. CDRH expects the qualification
process to expedite development of publicly available tools, which
could potentially be used widely in multiple device development
programs.
The intent of this voluntary MDDT program is to promote the
development and use of tools to streamline device development and
evaluation. Once an MDDT is submitted in accordance with the FDA
guidance entitled ``Requests for Feedback on Medical Device
Submissions: The Pre-Submission Program and Meetings with Food and Drug
Administration Staff'' (Ref. 1) and qualified for a specific context of
use, it can be used by any medical device sponsor for that context of
use. MDDTs can be used for the qualified context of use without the
need to reconfirm the suitability and utility of the MDDT when used in
a premarket submission. Qualification may contribute to acceptance and
application of MDDTs across multiple medical device development
programs. Qualified MDDTs can be utilized by many sponsors to aid in
optimizing device development and evaluation.
As discussed in the November 14, 2013, Federal Register notice (78
FR 68459), FDA announced the availability of the draft of this guidance
and interested persons were invited to comment by February 12, 2014. In
the August 15, 2014, Federal Register notice (79 FR 48170), FDA began
accepting nominations for participation in the voluntary MDDT Pilot
Program. FDA reviewed and considered all public comments received and
revised this guidance as appropriate.
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 ``Qualification of Medical Device
Development Tools.'' 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. Guidance
documents are also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``Qualification of Medical
Device Development Tools'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document.
Please use the document number 1882 to identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This guidance contains information collection that is 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 under the guidance entitled ``Requests for Feedback on
Medical Device Submissions: The Pre-Submission Program and Meetings
with Food and Drug Administration Staff'' have been approved under OMB
control number 0910-0756.
[[Page 37458]]
V. Reference
The following reference is on display in the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. FDA Guidance, ``Requests for Feedback on Medical Device
Submissions: The Pre-Submission Program and Meetings with Food and
Drug Administration Staff.'' Available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf.
Dated: August 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-16827 Filed 8-9-17; 8:45 am]
BILLING CODE 4164-01-P
