80 FR 10122 - Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 37 (February 25, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 37 (February 25, 2015)
| Page Range | 10122-10123 | |
| FR Document | 2015-03843 |
[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)] [Notices] [Pages 10122-10123] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03843] ----------------------------------------------------------------------- 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[Docket No. FDA-2015-D-0230] Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices.'' This draft guidance provides industry and Agency staff with recommendations regarding the technical performance assessment data that should be provided for regulatory evaluation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 This draft guidance is not final nor is it in effect at this time.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 26, 2015.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 Submit written requests for a single hard copy of the draft guidance document entitled ``Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices'' to the Office of the Center Director, Guidance and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 [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 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] BILLING CODE 4164-01-P
![10122 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices
The third comment asserted that we Although we agree with the PRA proceeding is to seek comment on
underestimated the reporting burden of commenter that information collection and obtain OMB approval for the NDIN
the NDIN procedures under § 190.6 by recommendations in guidance are collections of information in effect
failing to take into account the subject to the PRA, we intend to meet during this interim period, which are
recommendations in the draft guidance our PRA obligations in that regard those found in the FDA’s NDIN
entitled ‘‘Dietary Supplements: New separately at a later time. The 2011 draft regulations at § 190.6 and in the
Dietary Ingredient Notifications and guidance was published solely for the electronic NDIN submission forms that
Related Issues’’ (the 2011 draft purpose of seeking comment, and it has we have made available for comment.
guidance) (available at http:// not been made final. Moreover, FDA After publishing a revised draft
www.fda.gov/Food/Guidance intends to publish a revised draft guidance on NDINs and related issues,
Regulation/GuidanceDocuments guidance for comment later this year, we intend to publish a 60-day notice
RegulatoryInformation/ and the revised draft guidance will inviting comment on the proposed
supersede the 2011 draft guidance. collections of information associated
DietarySupplements/ucm257563.htm).
Although we expect the revised draft with that document. At that time, we
FDA announced the availability of the
guidance to be followed by a final will carefully evaluate all comments we
2011 draft guidance for comment in a guidance, there will be an interim receive.
notice published in the Federal Register period where no guidance on NDINs is We estimate the burden of this
of July 5, 2011 (76 FR 39111). in effect. The purpose of the current collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response
190.6 .................................................................................... 55 1 55 20 1,100
1 There are no operating and maintenance costs associated with this collection of information.
We believe that the burden of the manufacturer or distributor to extract DEPARTMENT OF HEALTH AND
premarket notification requirement on and summarize information that should HUMAN SERVICES
industry is limited and reasonable have already been developed to meet
because we are requesting only safety the safety requirement in section Food and Drug Administration
and identity information that the 413(a)(2) of the FD&C Act. We estimate [Docket No. FDA–2015–D–0230]
manufacturer or distributor should that extracting and summarizing the
already have developed to satisfy itself relevant information from what exists in Technical Performance Assessment of
that a dietary supplement containing a the company’s files and presenting it in Digital Pathology Whole Slide Imaging
new dietary ingredient is in compliance a format that meets the requirements of Devices; Draft Guidance for Industry
with the FD&C Act. In the past, § 190.6 will take approximately 20 and Food and Drug Administration
commenters have argued that our hours of work per notification. Staff; Availability
burden estimate is too low. We carefully
However, we seek comments on this AGENCY: Food and Drug Administration,
considered the issue and believe that
estimate. We encourage comments HHS.
burden estimates of greater than 20
hours per notification likely include the offering alternative burden estimates to ACTION: Notice.
burden associated with researching and include documentation to support the
generating safety data for a new dietary alternative estimate. SUMMARY: The Food and Drug
ingredient. Under section 413(a)(2) of We further estimate that 55 Administration (FDA) is announcing the
the FD&C Act, a dietary supplement that respondents will submit 1 premarket availability of a draft guidance entitled
contains a new dietary ingredient is notification each. We base our estimate ‘‘Technical Performance Assessment of
deemed to be adulterated unless there is of the number of respondents on Digital Pathology Whole Slide Imaging
a history of use or other evidence of Devices.’’ This draft guidance provides
notifications received over the past 3
safety establishing that the new dietary industry and Agency staff with
years, which averaged about 55
ingredient will reasonably be expected recommendations regarding the
notifications per year. technical performance assessment data
to be safe under the conditions of use
recommended or suggested in the Dated: February 19, 2015. that should be provided for regulatory
labeling of the dietary supplement. This Leslie Kux, evaluation of a digital whole slide
requirement is separate from and Associate Commissioner for Policy. imaging (WSI) system. This draft
additional to the requirement to submit [FR Doc. 2015–03833 Filed 2–24–15; 8:45 am]
guidance is not final nor is it in effect
a premarket notification for the new at this time.
BILLING CODE 4164–01–P
dietary ingredient. FDA’s regulation on DATES: Although you can comment on
NDINs, § 190.6(a), requires the any guidance at any time (see 21 CFR
asabaliauskas on DSK5VPTVN1PROD with NOTICES
manufacturer or distributor of the 10.115(g)(5)), to ensure that the Agency
dietary supplement, or of the new considers your comment of this draft
dietary ingredient, to submit to FDA the guidance before it begins work on the
information that forms the basis for its final version of the guidance, submit
conclusion that a dietary supplement either electronic or written comments
containing the new dietary ingredient on the draft guidance by May 26, 2015.
will reasonably be expected to be safe. ADDRESSES: An electronic copy of the
Thus, § 190.6 only requires the guidance document is available for
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![Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10123
download from the Internet. See the guidance provides our suggestions on or written comments to the Division of
SUPPLEMENTARY INFORMATION section for how to best characterize the technical Dockets Management (see ADDRESSES). It
information on electronic access to the aspects that are relevant to WSI is only necessary to send one set of
guidance. Submit written requests for a performance for their intended use and comments. Identify comments with the
single hard copy of the draft guidance determine any possible limitations that docket number found in brackets in the
document entitled ‘‘Technical might affect their safety and heading of this document. Received
Performance Assessment of Digital effectiveness. comments may be seen in the Division
Pathology Whole Slide Imaging of Dockets Management between 9 a.m.
II. Significance of Guidance
Devices’’ to the Office of the Center and 4 p.m., Monday through Friday, and
Director, Guidance and Policy This draft guidance is being issued will be posted to the docket at http://
Development, Center for Devices and consistent with FDA’s good guidance www.regulations.gov.
Radiological Health, Food and Drug practices regulation (21 CFR 10.115).
Dated: February 19, 2015.
Administration, 10903 New Hampshire The draft guidance, when finalized, will
represent the Agency’s current thinking Leslie Kux,
Ave., Bldg. 66, Rm. 5431, Silver Spring,
on technical performance assessment of Associate Commissioner for Policy.
MD 20993–0002. Send one self-
digital pathology WSI devices. It does [FR Doc. 2015–03843 Filed 2–24–15; 8:45 am]
addressed adhesive label to assist that
office in processing your request. not create or confer any rights for or on BILLING CODE 4164–01–P
Submit electronic comments on the any person and does not operate to bind
draft guidance to http:// FDA or the public. An alternative
www.regulations.gov. Submit written approach may be used if such approach DEPARTMENT OF HEALTH AND
comments to the Division of Dockets satisfies the requirements of the HUMAN SERVICES
Management (HFA–305), Food and Drug applicable statute and regulations.
Food and Drug Administration
Administration, 5630 Fishers Lane, Rm. III. Electronic Access
1061, Rockville, MD 20852. Identify [Docket No. FDA–2015–N–0001]
comments with the docket number Persons interested in obtaining a copy
found in brackets in the heading of this of the draft guidance may do so by Pediatric Ethics Subcommittee of the
document. downloading an electronic copy from Pediatric Advisory Committee; Notice
the Internet. A search capability for all of Meeting
FOR FURTHER INFORMATION CONTACT:
Center for Devices and Radiological
Nicholas Anderson, Center for Devices Health guidance documents is available AGENCY: Food and Drug Administration,
and Radiological Health, Food and Drug at http://www.fda.gov/MedicalDevices/ HHS.
Administration, 10903 New Hampshire DeviceRegulationandGuidance/ ACTION: Notice.
Ave., Bldg. 66, Rm. 5570, Silver Spring, GuidanceDocuments/default.htm.
MD 20993–0002, 301–796–4310; or Guidance documents are also available This notice announces a forthcoming
Aldo Badano, Center for Devices and at http://www.regulations.gov. Persons meeting of a public advisory committee
Radiological Health, Food and Drug unable to download an electronic copy of the Food and Drug Administration
Administration, 10903 New Hampshire of ‘‘Technical Performance Assessment (FDA). The meeting will be open to the
Ave., Bldg. 62, Rm. 3116, Silver Spring, of Digital Pathology Whole Slide public.
MD 20993–0002, 301–796–2534. Imaging Devices’’ may send an email Name of Committee: Pediatric Ethics
SUPPLEMENTARY INFORMATION: request to CDRH-Guidance@fda.hhs.gov Subcommittee of the Pediatric Advisory
to receive an electronic copy of the Committee.
I. Background General Function of the Committee:
document. Please use the document
Recent technological advances in number 1400053 to identify the To provide advice and
digital microscopy, in particular the guidance you are requesting. recommendations to the Agency
development of whole slide scanning regarding ethical protections for
systems, have accelerated the adoption IV. Paperwork Reduction Act of 1995 children in FDA-regulated clinical
of digital imaging in pathology, similar This draft guidance refers to trials.
to the digital transformation that previously approved collections of Date and Time: The meeting will be
radiology departments have experienced information found in FDA regulations. held on Monday, March 23, 2015 from
over the last decade. FDA regulates WSI These collections of information are 8:30 a.m. to 4:30 p.m.
systems manufacturers to ensure that subject to review by the Office of Location: Doubletree by Hilton Hotel,
the images produced for clinical Management and Budget (OMB) under 8727 Colesville Rd., Silver Spring, MD
intended uses are safe and effective for the Paperwork Reduction Act of 1995 20910. Answers to commonly asked
such purposes. Essential to the (the PRA) (44 U.S.C. 3501–3520). The questions, including information
regulation of these systems is the collections of information in 21 CFR regarding special accommodations due
understanding of the technical part 807, subpart E have been approved to a disability, visitor parking, and
performance of the components in the under OMB control number 0910–0120, transportation, may be accessed at:
imaging chain, from image acquisition the collections of information in 21 CFR http://www.fda.gov/
to image display and their effect on part 814 have been approved under AdvisoryCommittees/
pathologist’s diagnostic performance OMB control number 0910–0231, and AboutAdvisoryCommittees/
and workflow. ucm408555.htm.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
the collections of information in 21 CFR
This draft guidance provides industry part 801 and 21 CFR 809.10 have been Contact Person: Walter Ellenberg,
and Agency staff with recommendations approved under OMB control number Office of the Commissioner, Food and
regarding the technical performance 0910–0485. Drug Administration, 10903 New
assessment data that should be included Hampshire Ave., Bldg. 32, rm. 5154,
for regulatory evaluation of a WSI. This V. Comments Silver Spring, MD 20993, 301–796–
document does not cover the clinical Interested persons may submit either 0885, email walter.ellenberg@
submission data that may be necessary electronic comments regarding this fda.hhs.gov, or FDA Advisory
to support approval or clearance. The document to http://www.regulations.gov Committee Information Line, 1–800–
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Document Created: 2015-12-18 13:08:31
Document Modified: 2015-12-18 13:08:31
| 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. | |
| 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. | |
| 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. | |
| FR Citation | 80 FR 10122 |
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