[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16364-16365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07824]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-4764]


Policy Clarification and Premarket Notification Submissions for 
Ultrasonic Diathermy Devices; 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 guidance entitled ``Policy Clarification and 
Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy 
Devices; Guidance for Industry and Food and Drug Administration 
Staff.'' This guidance clarifies FDA's policy related to compliance 
with applicable performance standards and conformance to International 
Electrotechnical Commission (IEC) consensus standards for ultrasonic 
diathermy devices. This guidance provides recommendations for 
information to provide in 510(k) submissions for ultrasonic diathermy 
devices.

DATES: The announcement of the guidance is published in the Federal 
Register on April 16, 2018.

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-4764 for ``Policy Clarification and Premarket Notification 
[510(k)] Submissions for Ultrasonic Diathermy Devices; 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 office 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

[[Page 16365]]

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 
``Policy Clarification and Premarket Notification [510(k)] Submissions 
for Ultrasonic Diathermy Devices; 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: Jismi Johnson, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993-0002, 301-796-6424.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry and 
FDA staff entitled ``Policy Clarification and Premarket Notification 
[510(k)] Submissions for Ultrasonic Diathermy Devices; Guidance for 
Industry and Food and Drug Administration Staff.'' Ultrasonic diathermy 
devices are class II medical devices regulated under 21 CFR 
890.5300(a), Ultrasonic diathermy. Ultrasonic therapy devices must also 
comply with FDA radiation safety performance standards in 21 CFR part 
1010, Performance standards for electronic products: General, and 21 
CFR 1050.10, Ultrasonic therapy products. FDA recognizes that there are 
several IEC standards with which other countries require conformance or 
recognize for ultrasonic therapy products. This means that 
manufacturers who distribute these products in the United States and 
other countries might have to ensure conformance of their products to 
IEC standards and comply with FDA performance standards. This may cause 
manufacturers to duplicate their efforts.
    This guidance clarifies FDA's policy related to compliance with 
applicable performance standards and conformance to IEC consensus 
standards for ultrasonic diathermy devices. If firms provide a 
declaration of conformity with the relevant provisions of the current 
FDA recognized versions of the IEC 60601-2-5 and IEC 61689 standards, 
FDA does not intend to consider whether firms comply with certain 
requirements of 21 CFR 1050.10. This guidance also provides 
recommendations for information to provide in 510(k) submissions for 
ultrasonic diathermy devices.
    No comments were received on the draft guidance that was published 
in the August 31, 2017, Federal Register notice (82 FR 41417).

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 policy clarification and premarket 
notification (510(k)) submissions for ultrasonic diathermy 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 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 unable to download an electronic copy of ``Policy Clarification 
and Premarket Notification [510(k)] Submissions for Ultrasonic 
Diathermy Devices; Guidance for Industry and Food and Drug 
Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 1500003 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This 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 (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 801 have been approved under OMB control 
number 0910-0485; 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 parts 1002 through 1050 are 
approved under OMB control number 0910-0025.

    Dated: April 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07824 Filed 4-13-18; 8:45 am]
 BILLING CODE 4164-01-P


