[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: 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