2019-07936. Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability  

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    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of availability.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions.” This draft guidance document provides recommendations on the information that should be included in premarket submissions for devices that include quantitative imaging functions. This draft guidance is not final nor is it in effect at this time.

    DATES:

    Submit either electronic or written comments on the draft guidance by June 18, 2019 to ensure that the Start Printed Page 16518Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

    ADDRESSES:

    You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    • For written/paper comments submitted to the Dockets Management Staff, 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-2019-D-1470 for “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions.” 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 Dockets Management Staff 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 Dockets Management Staff. 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 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.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

    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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

    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 draft guidance document entitled “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions” to the Office of Policy, 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.

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    FOR FURTHER INFORMATION CONTACT:

    Dina Jerebitski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-796-2411.

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    SUPPLEMENTARY INFORMATION:

    I. Background

    This draft guidance document provides recommendations on the information that should be included in premarket submissions for devices that include quantitative imaging functions. Medical imaging is used routinely in hospitals and clinics to assist with the diagnosis and management of patients with a variety of diseases and conditions, by providing visual representations of the internal structures of the body. Most medical images are acquired with the intention of qualitative interpretation by a trained physician to identify the presence or absence of a structure or feature. Quantitative imaging extracts additional information from medical images in the form of numerical values.

    This draft guidance document is applicable to all devices that generate quantitative imaging values across a wide range of imaging modalities, intended uses, levels of automation, and complexity of algorithm. For the purpose of this document, FDA considers quantitative imaging values to be objective characteristics measured on a ratio or interval scale; that is, measured parameters derived from medical images that have physical meaning.

    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 current thinking of FDA on “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions.” 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. This guidance is not subject to Executive Order 12866.

    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 https://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​default.htm. This guidance document is also available at https://www.regulations.gov. Persons Start Printed Page 16519unable to download an electronic copy of “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 18017 to identify the guidance you are requesting.

    IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of information. 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 the following FDA regulations and guidances have been approved by OMB as listed in the following table:

    21 CFR Part; guidance; or FDA formTopicOMB Control No.
    807, subpart EPremarket notification0910-0120
    814, subparts A through EPremarket approval0910-0231
    814, subpart HHumanitarian Device Exemption0910-0332
    812Investigational Device Exemption0910-0078
    “De Novo Classification Process (Evaluation of Automatic Class III Designation)”De Novo classification process0910-0844
    “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff”Q-submissions0910-0756
    800, 801, and 809Medical Device Labeling Regulations0910-0485
    Start Signature

    Dated: April 16, 2019.

    Lowell J. Schiller,

    Principal Associate Commissioner for Policy.

    End Signature End Supplemental Information

    [FR Doc. 2019-07936 Filed 4-18-19; 8:45 am]

    BILLING CODE 4164-01-P

Document Information

Published:
04/19/2019
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice of availability.
Document Number:
2019-07936
Dates:
Submit either electronic or written comments on the draft guidance by June 18, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Pages:
16517-16519 (3 pages)
Docket Numbers:
Docket No. FDA-2019-D-1470
PDF File:
2019-07936.Pdf
Supporting Documents:
» Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
» Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
» Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
» Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff