Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Guidance for Industry and Food and Drug Administration Staff; Availability, 23306-23307 [2016-09140]
Download as PDF
23306
Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices
Lhorne on DSK5TPTVN1PROD with NOTICES
patient and consumer advocacy groups,
veterinary professionals, and scientific
and academic experts. To initiate this
process of consultation, elsewhere in
this issue of the Federal Register, we are
announcing a public meeting to be held
on May 16, 2016, where stakeholders
and other members of the public will be
given an opportunity to present their
views on the reauthorization. The
meeting and written comments
submitted to the docket will provide
critical input as the Agency prepares for
reauthorization discussions. Section
740A(d)(3) of the FD&C Act further
requires that FDA continue meeting
with these stakeholders at least once
every 4 months during negotiations with
the regulated industry to continue
discussions of their views on the
reauthorization, including suggested
changes to the ADUFA program.
FDA is issuing this Federal Register
notice to request that stakeholders—
including veterinary, patient and
consumer groups, as well as scientific
and academic experts—notify FDA of
their intent to participate in the periodic
consultation meetings on ADUFA
reauthorization. FDA believes that
consistent stakeholder representation at
these meetings will be important to
ensure progress in these discussions. If
you wish to participate in this part of
the reauthorization process, please
designate one or more representatives
from your organization who will
commit to attending these meetings and
preparing for the discussions.
Stakeholders who identify themselves
through this notice will be included in
all future stakeholder discussion while
FDA negotiates with the regulated
industry. If a stakeholder decides to
participate in these meetings at a later
time, they may still participate in
remaining meetings by notifying FDA
(see ADDRESSES). These stakeholder
discussions will satisfy the requirement
in section 740A(d)(3) of the FD&C Act.
II. Notification of Intent To Participate
in Periodic Stakeholder Consultation
Meetings
If you intend to participate in
continued periodic stakeholder
consultation meetings regarding ADUFA
reauthorization, please submit
notification by email to cvmadufa@
fda.hhs.gov by May 16, 2016. Your
email should contain complete contact
information for each attendee, including
name, title, affiliation, address, email
address, telephone number, and notice
of any special accommodations required
due to a disability. Stakeholders will
receive confirmation and additional
information about the first meeting after
FDA receives this notification.
VerDate Sep<11>2014
14:53 Apr 19, 2016
Jkt 238001
Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–09151 Filed 4–19–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–0230]
Technical Performance Assessment of
Digital Pathology Whole Slide Imaging
Devices; Guidance for Industry and
Food and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance entitled ‘‘Technical
Performance Assessment of Digital
Pathology Whole Slide Imaging
Devices.’’ This guidance provides
industry and Agency staff with
recommendations regarding the
technical performance assessment data
for the evaluation of a digital whole
slide imaging (WSI) system. The
guidance provides suggestions on how
to best characterize the technical aspects
that are relevant to WSI performance for
their intended use and determine any
possible limitations that might affect
their safety and effectiveness.
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:
SUMMARY:
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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2015–D–0230 for ‘‘Technical
Performance Assessment of Digital
Pathology Whole Slide Imaging Devices;
Guidance for Industry and Food and
Drug Administration Staff.’’ 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 Division of Dockets
Management 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 Division of Dockets
Management. 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
E:\FR\FM\20APN1.SGM
20APN1
Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices
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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 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 ‘‘Technical
Performance Assessment of Digital
Pathology Whole Slide Imaging
Devices’’ 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 selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Nicholas Anderson, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5662, Silver Spring,
MD 20993–0002, 301–796–4310; or
Aldo Badano, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 62, Rm. 3116, Silver Spring,
MD 20993–0002, 301–796–2534.
SUPPLEMENTARY INFORMATION:
Lhorne on DSK5TPTVN1PROD with NOTICES
I. Background
Recent technological advances in
digital microscopy, in particular the
development of whole slide scanning
systems, have accelerated the adoption
of digital imaging in pathology, similar
to the digital transformation that
radiology departments have experienced
over the last decade. FDA regulates WSI
system manufacturers to help ensure
that the images produced for intended
clinical uses are safe and effective for
such purposes. Essential to the
regulation of these systems is the
understanding of the technical
VerDate Sep<11>2014
14:53 Apr 19, 2016
Jkt 238001
performance of the WSI system and the
components in the imaging chain—from
image acquisition to image display, and
their effect on pathologist’s diagnostic
performance and workflow.
This guidance provides industry and
Agency staff with recommendations
regarding the technical performance
assessment for regulatory evaluation of
a digital WSI system. This document
does not cover the clinical submission
data that may be necessary to support
approval or clearance. The guidance
provides suggestions on how to best
characterize the technical aspects that
are relevant to WSI performance for
their intended use and determine any
possible limitations that might affect
their safety and effectiveness.
In the Federal Register of February
25, 2015 (80 FR 10122), FDA announced
the availability of the draft guidance and
interested persons were invited to
comment by May 25, 2015.
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 technical
performance assessment of digital
pathology whole slide imaging devices.
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.
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 ‘‘Technical Performance Assessment
of Digital Pathology Whole Slide
Imaging Devices’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 1400053 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This 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
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
23307
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807, subpart E (premarket
notification) have been approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 814 (premarket approval) have been
approved under OMB control number
0910–0231; and the collections of
information in 21 CFR part 801 and 21
CFR 809.10 (labeling) have been
approved under OMB control number
0910–0485.
Dated: April 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–09140 Filed 4–19–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–3056]
Distributor Labeling for New Animal
Drugs; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of guidance
for industry #231 entitled ‘‘Distributor
Labeling for New Animal Drugs.’’ This
guidance discusses FDA’s current
thinking with respect to the factors it
considers in determining whether to
take regulatory action against distributor
labeling for a new animal drug that
differs from the labeling approved as
part of a new animal drug application or
abbreviated new animal drug
application in ways other than those
permitted by regulation.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
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
E:\FR\FM\20APN1.SGM
20APN1
Agencies
[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23306-23307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09140]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-0230]
Technical Performance Assessment of Digital Pathology Whole Slide
Imaging Devices; 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 guidance entitled ``Technical Performance
Assessment of Digital Pathology Whole Slide Imaging Devices.'' This
guidance provides industry and Agency staff with recommendations
regarding the technical performance assessment data for the evaluation
of a digital whole slide imaging (WSI) system. The guidance provides
suggestions on how to best characterize the technical aspects that are
relevant to WSI performance for their intended use and determine any
possible limitations that might affect their safety and effectiveness.
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2015-D-0230 for ``Technical Performance Assessment of Digital
Pathology Whole Slide Imaging Devices; Guidance for Industry and Food
and Drug Administration Staff.'' 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 Division of Dockets Management 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 Division of Dockets Management. 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
[[Page 23307]]
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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 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
``Technical Performance Assessment of Digital Pathology Whole Slide
Imaging Devices'' 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: Nicholas Anderson, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5662, Silver Spring, MD 20993-0002, 301-
796-4310; or Aldo Badano, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm.
3116, Silver Spring, MD 20993-0002, 301-796-2534.
SUPPLEMENTARY INFORMATION:
I. Background
Recent technological advances in digital microscopy, in particular
the development of whole slide scanning systems, have accelerated the
adoption of digital imaging in pathology, similar to the digital
transformation that radiology departments have experienced over the
last decade. FDA regulates WSI system manufacturers to help ensure that
the images produced for intended clinical uses are safe and effective
for such purposes. Essential to the regulation of these systems is the
understanding of the technical performance of the WSI system and the
components in the imaging chain--from image acquisition to image
display, and their effect on pathologist's diagnostic performance and
workflow.
This guidance provides industry and Agency staff with
recommendations regarding the technical performance assessment for
regulatory evaluation of a digital WSI system. This document does not
cover the clinical submission data that may be necessary to support
approval or clearance. The guidance provides suggestions on how to best
characterize the technical aspects that are relevant to WSI performance
for their intended use and determine any possible limitations that
might affect their safety and effectiveness.
In the Federal Register of February 25, 2015 (80 FR 10122), FDA
announced the availability of the draft guidance and interested persons
were invited to comment by May 25, 2015.
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 technical performance assessment of digital
pathology whole slide imaging devices. 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.
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 ``Technical Performance
Assessment of Digital Pathology Whole Slide Imaging Devices'' may send
an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic
copy of the document. Please use the document number 1400053 to
identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This 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 21 CFR part 807, subpart E (premarket
notification) have been approved under OMB control number 0910-0120;
the collections of information in 21 CFR part 814 (premarket approval)
have been approved under OMB control number 0910-0231; and the
collections of information in 21 CFR part 801 and 21 CFR 809.10
(labeling) have been approved under OMB control number 0910-0485.
Dated: April 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09140 Filed 4-19-16; 8:45 am]
BILLING CODE 4164-01-P