Document ID: FDA-2015-D-0230-0001
Agency: fda
Document Type: Notice
Title: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2015-02-25T05:00Z

[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10122-10123]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03843]

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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Imaging Devices; Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Technical Performance 
Assessment of Digital Pathology Whole Slide Imaging Devices.'' This 
draft guidance provides industry and Agency staff with recommendations 
regarding the technical performance assessment data that should be 
provided for regulatory evaluation of a digital whole slide imaging 
(WSI) system. This draft guidance is not final nor is it in effect at 
this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 26, 2015.

ADDRESSES: An electronic copy of the guidance document is available for

[[Page 10123]]

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requests for a single hard copy of the draft guidance document entitled 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.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nicholas Anderson, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5570, 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 systems manufacturers to ensure that the 
images produced for clinical intended uses are safe and effective for 
such purposes. Essential to the regulation of these systems is the 
understanding of the technical performance of the components in the 
imaging chain, from image acquisition to image display and their effect 
on pathologist's diagnostic performance and workflow.
    This draft guidance provides industry and Agency staff with 
recommendations regarding the technical performance assessment data 
that should be included for regulatory evaluation of a WSI. This 
document does not cover the clinical submission data that may be 
necessary to support approval or clearance. The guidance provides our 
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.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on technical 
performance assessment of digital pathology WSI devices. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statute and 
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft 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 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 draft 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 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 807, subpart E 
have been approved under OMB control number 0910-0120, the collections 
of information in 21 CFR part 814 have been approved under OMB control 
number 0910-0231, and the collections of information in 21 CFR part 801 
and 21 CFR 809.10 have been approved under OMB control number 0910-
0485.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: February 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03843 Filed 2-24-15; 8:45 am]
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