Document ID: FDA-2017-D-5372-0001
Agency: fda
Document Type: Notice
Title: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2017-10-02T04:00Z

[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Pages 45854-45856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21077]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5372]

Marketing Clearance of Diagnostic Ultrasound Systems and 
Transducers; Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Marketing Clearance 
of Diagnostic Ultrasound Systems and Transducers; Draft Guidance for 
Industry and Food and Drug Administration Staff.'' This draft guidance 
provides detailed information recommended for manufacturers seeking 
marketing clearance of diagnostic ultrasound systems and transducers. 
This draft guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by January 2, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

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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-2017-D-5372 for ``Marketing Clearance of Diagnostic Ultrasound 
Systems and Transducers; Draft 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 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 
``Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; 
Draft Guidance for Industry and Food and Drug Administration Staff'' 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: Shahram Vaezy, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4227A, Silver Spring, MD 20993-0002, 301-796-6242 
or Keith Wear, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 2104, 
Silver Spring, MD 20993-0002, 301-796-2538.

SUPPLEMENTARY INFORMATION: 

I. Background

    When finalized, this draft guidance will provide detailed 
recommendations for manufacturers seeking marketing clearance of 
diagnostic ultrasound systems and transducers. In addition, this draft 
guidance, when final, is intended to supersede FDA's 2008 guidance 
entitled, ``Information for Manufacturers Seeking Marketing Clearance 
of Diagnostic Ultrasound Systems and Transducers,'' regarding FDA's 
approach to the regulation of certain diagnostic ultrasound devices. 
(Ref. 1). In addition to the regulatory approaches outlined in the 2008 
document, additional guidance is provided for deciding when a device 
modification to a diagnostic ultrasound device can be made without the 
need for submission of a new premarket notification (510(k)) 
submission. As before, device sponsors who comply with the applicable 
premarket notification requirements will continue to be exempt from the 
Electronic Product Radiation Control reporting requirements in 21 CFR 
1002.12, for diagnostic ultrasound devices, as described in the notice 
to industry entitled ``Exemption from Reporting under 21 CFR 1002'' 
(dated February 24, 1986) (Ref. 2). When finalized, this draft guidance 
is applicable to diagnostic ultrasound devices under 21 CFR 892.1550 
(Ultrasonic pulsed doppler imaging system), 21 CFR 892.1560 (Ultrasonic 
pulsed echo imaging system), and 21 CFR 892.1570 (Diagnostic ultrasonic 
transducer).

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 ``Diagnostic 
Ultrasound Systems and Transducer 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. 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. Guidance 
documents are also available at https://www.regulations.gov. Persons 
unable to download an electronic copy of ``Marketing Clearance of 
Diagnostic Ultrasound Systems and Transducers; Draft Guidance for 
Industry and Food and Drug Administration Staff'' may send an email 
request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of 
the document. Please use the document number 560 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of

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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, have been 
approved under OMB control number 0910-0120, the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073, and the collections of information in 21 CFR part 801 
have been approved under OMB control number 0910-0485. The collections 
of information in 21 CFR parts 1002 and 1010 are approved under OMB 
control number 0910-0025.

V. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

    1. FDA Guidance, ``Information for Manufacturers Seeking 
Marketing Clearance of Diagnostic Ultrasound Systems and 
Transducers.'' Available at: https://www.fda.gov/downloads/UCM070911.pdf.
    2. FDA, ``Information for Industry.'' Available at: https://www.fda.gov/RadiationEmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm115357.htm

    Dated: September 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-21077 Filed 9-29-17; 8:45 am]
 BILLING CODE 4164-01-P