Document ID: FDA-2017-D-5372-0006
Agency: fda
Document Type: Notice
Title: Marketing Clearance of Diagnostic Ultrasound Systems and Transducers;
Guidance for Industry and Food and Drug Administration Staff; Availability
Posted Date: 2019-06-27T04:00Z

[Federal Register Volume 84, Number 124 (Thursday, June 27, 2019)]
[Notices]
[Pages 30720-30721]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13687]

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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; 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 a final guidance entitled ``Marketing Clearance of 
Diagnostic Ultrasound Systems and Transducers.'' This final guidance 
provides detailed recommendations for manufacturers seeking marketing 
clearance of diagnostic ultrasound systems and transducers, and 
includes guidance describing the types of modifications to a diagnostic 
ultrasound device for which FDA does not intend to enforce the 
requirement for a new premarket notification (510(k)).

DATES: The announcement of the guidance is published in the Federal 
Register on June 27, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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-2017-D-5372 for ``Marketing Clearance of Diagnostic Ultrasound 
Systems and Transducers.'' 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 guidance document entitled 
``Marketing Clearance of Diagnostic Ultrasound Systems and 
Transducers'' 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. 2114, 
Silver Spring, MD 20993-0002, 301-796-2538.

SUPPLEMENTARY INFORMATION: 

I. Background

    This guidance provides detailed recommendations for manufacturers 
seeking marketing clearance of diagnostic ultrasound systems and 
transducers. This guidance supersedes FDA's guidance entitled 
``Information for Manufacturers Seeking Marketing Clearance of 
Diagnostic Ultrasound Systems and Transducers'' dated September 9, 
2008, regarding FDA's approach to the regulation of certain diagnostic 
ultrasound devices.
    In addition to outlining regulatory approaches for certain 
diagnostic ultrasound devices, this guidance describes the types of 
modifications to a diagnostic ultrasound device for which FDA does not 
intend to enforce the requirement for a new 510(k). As

[[Page 30721]]

before, manufacturers who submit 510(k)s and receive marketing 
clearance 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.\1\
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    \1\ Available at https://www.fda.gov/downloads/Radiation-EmittingProducts/RadiationEmitting ProductsandProcedures/
MedicalImaging/UCM509874.pdf.
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    FDA considered comments received on the draft guidance that 
appeared in the Federal Register of October 2, 2017 (82 FR 45856). FDA 
revised the guidance as appropriate in response to the comments.

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 information for manufacturers seeking 
marketing clearance of diagnostic ultrasound systems and transducers. 
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 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov. Persons unable to download an 
electronic copy of ``Marketing Clearance of Diagnostic Ultrasound 
Systems and Transducers'' 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 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 guidance have been approved by OMB as 
listed in the following:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
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807, subpart E....................  Premarket                  0910-0120
                                     Notification.
801...............................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
1002 and 1010.....................  Reporting and              0910-0025
                                     Recordkeeping for
                                     Electronic
                                     Products--General
                                     Requirements.
814, subpart A-E..................  Premarket Approval         0910-0231
                                     of Medical Devices.
513(f)(2) FD&C Act................  De Novo                    0910-0844
                                     Classification
                                     Process (Evaluation
                                     of Automatic Class
                                     III Designation).
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
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    Dated: June 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13687 Filed 6-26-19; 8:45 am]
 BILLING CODE 4164-01-P