81 FR 23306 - Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 76 (April 20, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 76 (April 20, 2016)
| Page Range | 23306-23307 | |
| FR Document | 2016-09140 |
[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)] [Notices] [Pages 23306-23307] From the Federal Register Online [www.thefederalregister.org] [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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://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 [email protected] 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
![23306 Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices
patient and consumer advocacy groups, Dated: April 12, 2016. information, or other information that
veterinary professionals, and scientific Leslie Kux, identifies you in the body of your
and academic experts. To initiate this Associate Commissioner for Policy. comments, that information will be
process of consultation, elsewhere in [FR Doc. 2016–09151 Filed 4–19–16; 8:45 am] posted on http://www.regulations.gov.
this issue of the Federal Register, we are BILLING CODE 4164–01–P
• If you want to submit a comment
announcing a public meeting to be held with confidential information that you
on May 16, 2016, where stakeholders do not wish to be made available to the
and other members of the public will be DEPARTMENT OF HEALTH AND public, submit the comment as a
given an opportunity to present their HUMAN SERVICES written/paper submission and in the
views on the reauthorization. The manner detailed (see ‘‘Written/Paper
meeting and written comments Food and Drug Administration Submissions’’ and ‘‘Instructions’’).
submitted to the docket will provide [Docket No. FDA–2015–D–0230] Written/Paper Submissions
critical input as the Agency prepares for
reauthorization discussions. Section Technical Performance Assessment of Submit written/paper submissions as
740A(d)(3) of the FD&C Act further Digital Pathology Whole Slide Imaging follows:
requires that FDA continue meeting • Mail/Hand delivery/Courier (for
Devices; Guidance for Industry and
with these stakeholders at least once written/paper submissions): Division of
Food and Drug Administration Staff;
every 4 months during negotiations with Dockets Management (HFA–305), Food
Availability
the regulated industry to continue and Drug Administration, 5630 Fishers
discussions of their views on the AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
reauthorization, including suggested HHS. • For written/paper comments
changes to the ADUFA program. ACTION: Notice of availability. submitted to the Division of Dockets
FDA is issuing this Federal Register Management, FDA will post your
notice to request that stakeholders— SUMMARY: The Food and Drug comment, as well as any attachments,
including veterinary, patient and Administration (FDA or Agency) is except for information submitted,
consumer groups, as well as scientific announcing the availability of a marked and identified, as confidential,
and academic experts—notify FDA of guidance entitled ‘‘Technical if submitted as detailed in
their intent to participate in the periodic Performance Assessment of Digital ‘‘Instructions.’’
consultation meetings on ADUFA Pathology Whole Slide Imaging Instructions: All submissions received
reauthorization. FDA believes that Devices.’’ This guidance provides must include the Docket No. FDA–
consistent stakeholder representation at industry and Agency staff with 2015–D–0230 for ‘‘Technical
these meetings will be important to recommendations regarding the Performance Assessment of Digital
ensure progress in these discussions. If technical performance assessment data Pathology Whole Slide Imaging Devices;
you wish to participate in this part of for the evaluation of a digital whole Guidance for Industry and Food and
the reauthorization process, please slide imaging (WSI) system. The Drug Administration Staff.’’ Received
designate one or more representatives guidance provides suggestions on how comments will be placed in the docket
from your organization who will to best characterize the technical aspects and, except for those submitted as
commit to attending these meetings and that are relevant to WSI performance for ‘‘Confidential Submissions,’’ publicly
preparing for the discussions. their intended use and determine any viewable at http://www.regulations.gov
Stakeholders who identify themselves possible limitations that might affect or at the Division of Dockets
through this notice will be included in their safety and effectiveness. Management between 9 a.m. and 4 p.m.,
all future stakeholder discussion while DATES: Submit either electronic or Monday through Friday.
FDA negotiates with the regulated written comments on this guidance at • Confidential Submissions—To
industry. If a stakeholder decides to any time. General comments on Agency submit a comment with confidential
participate in these meetings at a later guidance documents are welcome at any information that you do not wish to be
time, they may still participate in time. made publicly available, submit your
remaining meetings by notifying FDA ADDRESSES: You may submit comments comments only as a written/paper
(see ADDRESSES). These stakeholder as follows: submission. You should submit two
discussions will satisfy the requirement copies total. One copy will include the
Electronic Submissions information you claim to be confidential
in section 740A(d)(3) of the FD&C Act.
Submit electronic comments in the with a heading or cover note that states
II. Notification of Intent To Participate following way: ‘‘THIS DOCUMENT CONTAINS
in Periodic Stakeholder Consultation • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The
Meetings www.regulations.gov. Follow the Agency will review this copy, including
If you intend to participate in instructions for submitting comments. the claimed confidential information, in
continued periodic stakeholder Comments submitted electronically, its consideration of comments. The
consultation meetings regarding ADUFA including attachments, to http:// second copy, which will have the
reauthorization, please submit www.regulations.gov will be posted to claimed confidential information
notification by email to cvmadufa@ the docket unchanged. Because your redacted/blacked out, will be available
fda.hhs.gov by May 16, 2016. Your comment will be made public, you are for public viewing and posted on http://
email should contain complete contact solely responsible for ensuring that your www.regulations.gov. Submit both
information for each attendee, including comment does not include any copies to the Division of Dockets
Lhorne on DSK5TPTVN1PROD with NOTICES
name, title, affiliation, address, email confidential information that you or a Management. If you do not wish your
address, telephone number, and notice third party may not wish to be posted, name and contact information to be
of any special accommodations required such as medical information, your or made publicly available, you can
due to a disability. Stakeholders will anyone else’s Social Security number, or provide this information on the cover
receive confirmation and additional confidential business information, such sheet and not in the body of your
information about the first meeting after as a manufacturing process. Please note comments and you must identify this
FDA receives this notification. that if you include your name, contact information as ‘‘confidential.’’ Any
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![Federal Register / Vol. 81, No. 76 / Wednesday, April 20, 2016 / Notices 23307
information marked as ‘‘confidential’’ performance of the WSI system and the Reduction Act of 1995 (44 U.S.C. 3501–
will not be disclosed except in components in the imaging chain—from 3520). The collections of information in
accordance with 21 CFR 10.20 and other image acquisition to image display, and 21 CFR part 807, subpart E (premarket
applicable disclosure law. For more their effect on pathologist’s diagnostic notification) have been approved under
information about FDA’s posting of performance and workflow. OMB control number 0910–0120; the
comments to public dockets, see 80 FR This guidance provides industry and collections of information in 21 CFR
56469, September 18, 2015, or access Agency staff with recommendations part 814 (premarket approval) have been
the information at: http://www.fda.gov/ regarding the technical performance approved under OMB control number
regulatoryinformation/dockets/ assessment for regulatory evaluation of 0910–0231; and the collections of
default.htm. a digital WSI system. This document information in 21 CFR part 801 and 21
Docket: For access to the docket to does not cover the clinical submission CFR 809.10 (labeling) have been
read background documents or the data that may be necessary to support approved under OMB control number
electronic and written/paper comments approval or clearance. The guidance 0910–0485.
received, go to http:// provides suggestions on how to best Dated: April 13, 2016.
www.regulations.gov and insert the characterize the technical aspects that
Leslie Kux,
docket number, found in brackets in the are relevant to WSI performance for
their intended use and determine any Associate Commissioner for Policy.
heading of this document, into the
possible limitations that might affect [FR Doc. 2016–09140 Filed 4–19–16; 8:45 am]
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets their safety and effectiveness. BILLING CODE 4164–01–P
Management, 5630 Fishers Lane, Rm. In the Federal Register of February
1061, Rockville, MD 20852. 25, 2015 (80 FR 10122), FDA announced
An electronic copy of the guidance the availability of the draft guidance and DEPARTMENT OF HEALTH AND
document is available for download interested persons were invited to HUMAN SERVICES
from the Internet. See the comment by May 25, 2015.
Food and Drug Administration
SUPPLEMENTARY INFORMATION section for II. Significance of Guidance
information on electronic access to the [Docket No. FDA–2015–D–3056]
guidance. Submit written requests for a This guidance is being issued
single hard copy of the guidance consistent with FDA’s good guidance Distributor Labeling for New Animal
document entitled ‘‘Technical practices regulation (21 CFR 10.115). Drugs; Guidance for Industry;
Performance Assessment of Digital The guidance represents the current Availability
Pathology Whole Slide Imaging thinking of FDA on technical
AGENCY: Food and Drug Administration,
Devices’’ to the Office of the Center performance assessment of digital
HHS.
Director, Guidance and Policy pathology whole slide imaging devices.
It does not establish any rights for any ACTION: Notice of availability.
Development, Center for Devices and
Radiological Health, Food and Drug person and is not binding on FDA or the SUMMARY: The Food and Drug
Administration, 10903 New Hampshire public. You can use an alternative Administration (FDA or Agency) is
Ave., Bldg. 66, Rm. 5431, Silver Spring, approach if it satisfies the requirements announcing the availability of guidance
MD 20993–0002. Send one self- of the applicable statutes and for industry #231 entitled ‘‘Distributor
addressed adhesive label to assist that regulations. Labeling for New Animal Drugs.’’ This
office in processing your request. III. Electronic Access guidance discusses FDA’s current
FOR FURTHER INFORMATION CONTACT: Persons interested in obtaining a copy thinking with respect to the factors it
Nicholas Anderson, Center for Devices of the guidance may do so by considers in determining whether to
and Radiological Health, Food and Drug downloading an electronic copy from take regulatory action against distributor
Administration, 10903 New Hampshire the Internet. A search capability for all labeling for a new animal drug that
Ave., Bldg. 66, Rm. 5662, Silver Spring, Center for Devices and Radiological differs from the labeling approved as
MD 20993–0002, 301–796–4310; or Health guidance documents is available part of a new animal drug application or
Aldo Badano, Center for Devices and at http://www.fda.gov/MedicalDevices/ abbreviated new animal drug
Radiological Health, Food and Drug DeviceRegulationandGuidance/ application in ways other than those
Administration, 10903 New Hampshire GuidanceDocuments/default.htm. permitted by regulation.
Ave., Bldg. 62, Rm. 3116, Silver Spring, Guidance documents are also available DATES: Submit either electronic or
MD 20993–0002, 301–796–2534. at http://www.regulations.gov. Persons written comments on Agency guidances
SUPPLEMENTARY INFORMATION: unable to download an electronic copy at any time.
of ‘‘Technical Performance Assessment ADDRESSES: You may submit comments
I. Background
of Digital Pathology Whole Slide as follows:
Recent technological advances in Imaging Devices’’ may send an email
digital microscopy, in particular the Electronic Submissions
request to CDRH-Guidance@fda.hhs.gov
development of whole slide scanning to receive an electronic copy of the Submit electronic comments in the
systems, have accelerated the adoption document. Please use the document following way:
of digital imaging in pathology, similar number 1400053 to identify the • Federal eRulemaking Portal: http://
to the digital transformation that guidance you are requesting. www.regulations.gov. Follow the
radiology departments have experienced instructions for submitting comments.
IV. Paperwork Reduction Act of 1995
Lhorne on DSK5TPTVN1PROD with NOTICES
over the last decade. FDA regulates WSI Comments submitted electronically,
system manufacturers to help ensure This guidance refers to previously including attachments, to http://
that the images produced for intended approved collections of information www.regulations.gov will be posted to
clinical uses are safe and effective for found in FDA regulations. These the docket unchanged. Because your
such purposes. Essential to the collections of information are subject to comment will be made public, you are
regulation of these systems is the review by the Office of Management and solely responsible for ensuring that your
understanding of the technical Budget (OMB) under the Paperwork comment does not include any
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Document Created: 2016-04-20 01:51:34
Document Modified: 2016-04-20 01:51:34
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| 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. | |
| FR Citation | 81 FR 23306 |
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