83 FR 16364 - Policy Clarification and Premarket Notification Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 73 (April 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 73 (April 16, 2018)
| Page Range | 16364-16365 | |
| FR Document | 2018-07824 |
[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)] [Notices] [Pages 16364-16365] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07824] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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.thefederalregister.org/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 CDRH-Guidance@fda.hhs.gov 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
![16364 Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
SOAR Specialized T/TA Feedback Form ........................................................ 200 1 .150 30.00
Webinar Participant Feedback Form ............................................................... 1000 1 .067 67.00
Survivor Impact Consultant Application ........................................................... 20 1 .283 5.66
Expert T/TA Consultant Application ................................................................. 20 1 .267 5.34
Organizational Scholarship Application ........................................................... 10 1 .317 3.17
Professional Development Survivor Scholarship Application .......................... 30 1 .333 9.99
Total Annual Burden ................................................................................. 5,908 ........................ ........................ 689.15
Estimated Total Annual Burden DEPARTMENT OF HEALTH AND solely responsible for ensuring that your
Hours: 689 Hours. HUMAN SERVICES comment does not include any
In compliance with the requirements confidential information that you or a
Food and Drug Administration third party may not wish to be posted,
of the Paperwork Reduction Act of 1995
[Docket No. FDA–2017–D–4764] such as medical information, your or
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
anyone else’s Social Security number, or
Administration for Children and
Policy Clarification and Premarket confidential business information, such
Families is soliciting public comment as a manufacturing process. Please note
Notification Submissions for
on the specific aspects of the that if you include your name, contact
Ultrasonic Diathermy Devices;
information collection described above. information, or other information that
Guidance for Industry and Food and
Copies of the proposed collection of Drug Administration Staff; Availability identifies you in the body of your
information can be obtained and comments, that information will be
comments may be forwarded by writing AGENCY: Food and Drug Administration, posted on https://www.regulations.gov.
to the Administration for Children and HHS. • If you want to submit a comment
Families, Office of Planning, Research ACTION: Notice of availability. with confidential information that you
and Evaluation, 330 C Street SW, do not wish to be made available to the
SUMMARY: The Food and Drug
Washington, DC 20201. Attn: ACF Administration (FDA or Agency) is public, submit the comment as a
Reports Clearance Officer. Email announcing the availability of the written/paper submission and in the
address: infocollection@acf.hhs.gov. All guidance entitled ‘‘Policy Clarification manner detailed (see ‘‘Written/Paper
requests should be identified by the title and Premarket Notification [510(k)] Submissions’’ and ‘‘Instructions’’).
of the information collection. Submissions for Ultrasonic Diathermy Written/Paper Submissions
The Department specifically requests Devices; Guidance for Industry and Submit written/paper submissions as
comments on: (a) Whether the proposed Food and Drug Administration Staff.’’ follows:
collection of information is necessary This guidance clarifies FDA’s policy • Mail/Hand Delivery/Courier (for
for the proper performance of the related to compliance with applicable written/paper submissions): Dockets
functions of the agency, including performance standards and Management Staff (HFA–305), Food and
whether the information shall have conformance to International Drug Administration, 5630 Fishers
practical utility; (b) the accuracy of the Electrotechnical Commission (IEC) Lane, Rm. 1061, Rockville, MD 20852.
consensus standards for ultrasonic • For written/paper comments
agency’s estimate of the burden of the
diathermy devices. This guidance submitted to the Dockets Management
proposed collection of information; (c)
provides recommendations for Staff, FDA will post your comment, as
the quality, utility, and clarity of the information to provide in 510(k)
information to be collected; and (d) well as any attachments, except for
submissions for ultrasonic diathermy information submitted, marked and
ways to minimize the burden of the devices.
collection of information on identified, as confidential, if submitted
respondents, including through the use DATES: The announcement of the as detailed in ‘‘Instructions.’’
guidance is published in the Federal Instructions: All submissions received
of automated collection techniques or
Register on April 16, 2018. must include the Docket No. FDA–
other forms of information technology. 2017–D–4764 for ‘‘Policy Clarification
ADDRESSES: You may submit either
Consideration will be given to and Premarket Notification [510(k)]
comments and suggestions submitted electronic or written comments on
Agency guidances at any time as Submissions for Ultrasonic Diathermy
within 60 days of this publication. Devices; Guidance for Industry and
follows:
Robert Sargis, Food and Drug Administration Staff.’’
Electronic Submissions Received comments will be placed in
Reports Clearance Officer.
Submit electronic comments in the the docket and, except for those
[FR Doc. 2018–07843 Filed 4–13–18; 8:45 am]
following way: submitted as ‘‘Confidential
BILLING CODE 4184–47–P • Federal eRulemaking Portal: Submissions,’’ publicly viewable at
srobinson on DSK3G9T082PROD with NOTICES
https://www.regulations.gov. Follow the https://www.regulations.gov or at the
instructions for submitting comments. Dockets Management Staff office
Comments submitted electronically, between 9 a.m. and 4 p.m., Monday
including attachments, to https:// through Friday.
www.regulations.gov will be posted to • Confidential Submissions—To
the docket unchanged. Because your submit a comment with confidential
comment will be made public, you are information that you do not wish to be
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![Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices 16365
made publicly available, submit your 0002. Send one self-addressed adhesive practices regulation (21 CFR 10.115).
comments only as a written/paper label to assist that office in processing The guidance represents the current
submission. You should submit two your request. thinking of FDA on policy clarification
copies total. One copy will include the FOR FURTHER INFORMATION CONTACT: and premarket notification (510(k))
information you claim to be confidential Jismi Johnson, Center for Devices and submissions for ultrasonic diathermy
with a heading or cover note that states Radiological Health, Food and Drug devices. It does not establish any rights
‘‘THIS DOCUMENT CONTAINS Administration, 10903 New Hampshire for any person and is not binding on
CONFIDENTIAL INFORMATION.’’ The Ave., Bldg. 66, Rm. 1524, Silver Spring, FDA or the public. You can use an
Agency will review this copy, including MD 20993–0002, 301–796–6424. alternative approach if it satisfies the
the claimed confidential information, in requirements of the applicable statutes
SUPPLEMENTARY INFORMATION:
its consideration of comments. The and regulations. This guidance is not
second copy, which will have the I. Background subject to Executive Order 12866.
claimed confidential information
FDA is announcing the availability of III. Electronic Access
redacted/blacked out, will be available
a guidance for industry and FDA staff
for public viewing and posted on Persons interested in obtaining a copy
https://www.regulations.gov. Submit entitled ‘‘Policy Clarification and
Premarket Notification [510(k)] of the guidance may do so by
both copies to the Dockets Management
Submissions for Ultrasonic Diathermy downloading an electronic copy from
Staff. If you do not wish your name and
Devices; Guidance for Industry and the internet. A search capability for all
contact information to be made publicly
Food and Drug Administration Staff.’’ Center for Devices and Radiological
available, you can provide this
Ultrasonic diathermy devices are class II Health guidance documents is available
information on the cover sheet and not
medical devices regulated under 21 CFR at https://www.fda.gov/MedicalDevices/
in the body of your comments and you
890.5300(a), Ultrasonic diathermy. DeviceRegulationandGuidance/
must identify this information as
Ultrasonic therapy devices must also GuidanceDocuments/default.htm. This
‘‘confidential.’’ Any information marked
comply with FDA radiation safety guidance document is also available at
as ‘‘confidential’’ will not be disclosed
performance standards in 21 CFR part https://www.regulations.gov. Persons
except in accordance with 21 CFR 10.20
1010, Performance standards for unable to download an electronic copy
and other applicable disclosure law. For
electronic products: General, and 21 of ‘‘Policy Clarification and Premarket
more information about FDA’s posting
of comments to public dockets, see 80 CFR 1050.10, Ultrasonic therapy Notification [510(k)] Submissions for
FR 56469, September 18, 2015, or access products. FDA recognizes that there are Ultrasonic Diathermy Devices; Guidance
the information at: https://www.gpo.gov/ several IEC standards with which other for Industry and Food and Drug
fdsys/pkg/FR-2015-09-18/pdf/2015- countries require conformance or Administration Staff’’ may send an
23389.pdf. recognize for ultrasonic therapy email request to CDRH-Guidance@
Docket: For access to the docket to products. This means that fda.hhs.gov to receive an electronic
read background documents or the manufacturers who distribute these copy of the document. Please use the
electronic and written/paper comments products in the United States and other document number 1500003 to identify
received, go to https:// countries might have to ensure the guidance you are requesting.
www.regulations.gov and insert the conformance of their products to IEC IV. Paperwork Reduction Act of 1995
docket number, found in brackets in the standards and comply with FDA
heading of this document, into the performance standards. This may cause This guidance refers to previously
‘‘Search’’ box and follow the prompts manufacturers to duplicate their efforts. approved collections of information
and/or go to the Dockets Management This guidance clarifies FDA’s policy found in FDA regulations. These
Staff, 5630 Fishers Lane, Rm. 1061, related to compliance with applicable collections of information are subject to
Rockville, MD 20852. performance standards and review by the Office of Management and
You may submit comments on any conformance to IEC consensus Budget (OMB) under the Paperwork
guidance at any time (see 21 CFR standards for ultrasonic diathermy Reduction Act of 1995 (44 U.S.C. 3501–
10.115(g)(5)). devices. If firms provide a declaration of 3520). The collections of information in
An electronic copy of the guidance conformity with the relevant provisions 21 CFR part 807, subpart E have been
document is available for download of the current FDA recognized versions approved under OMB control number
from the internet. See the of the IEC 60601–2–5 and IEC 61689 0910–0120; the collections of
SUPPLEMENTARY INFORMATION section for standards, FDA does not intend to information in 21 CFR part 801 have
information on electronic access to the consider whether firms comply with been approved under OMB control
guidance. Submit written requests for a certain requirements of 21 CFR 1050.10. number 0910–0485; the collections of
single hard copy of the guidance This guidance also provides information in 21 CFR part 820 have
document entitled ‘‘Policy Clarification recommendations for information to been approved under OMB control
and Premarket Notification [510(k)] provide in 510(k) submissions for number 0910–0073; and the collections
Submissions for Ultrasonic Diathermy ultrasonic diathermy devices. of information in 21 CFR parts 1002
Devices; Guidance for Industry and No comments were received on the through 1050 are approved under OMB
Food and Drug Administration Staff ’’ to draft guidance that was published in the control number 0910–0025.
the Office of the Center Director, August 31, 2017, Federal Register
Dated: April 10, 2018.
srobinson on DSK3G9T082PROD with NOTICES
Guidance and Policy Development, notice (82 FR 41417).
Center for Devices and Radiological Leslie Kux,
II. Significance of Guidance Associate Commissioner for Policy.
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, This guidance is being issued [FR Doc. 2018–07824 Filed 4–13–18; 8:45 am]
Rm. 5431, Silver Spring, MD 20993– consistent with FDA’s good guidance BILLING CODE 4164–01–P
VerDate Sep<11>2014 19:42 Apr 13, 2018 Jkt 244001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\16APN1.SGM 16APN1](https://thefederalregister.org/doc/83_FR_16437/page/2.svg)
Document Created: 2018-04-14 02:19:08
Document Modified: 2018-04-14 02:19:08
| 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 of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on April 16, 2018. | |
| 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. | |
| FR Citation | 83 FR 16364 |
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