82 FR 41417 - Policy Clarification and Premarket Notification (510(k)) Submissions for Ultrasonic Diathermy Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 168 (August 31, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 168 (August 31, 2017)
| Page Range | 41417-41418 | |
| FR Document | 2017-18470 |
[Federal Register Volume 82, Number 168 (Thursday, August 31, 2017)] [Notices] [Pages 41417-41418] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18470] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-D-4764] Policy Clarification and Premarket Notification (510(k)) Submissions for Ultrasonic Diathermy Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices--Draft Guidance for Industry and Food and Drug Administration Staff.'' When final, this draft guidance will clarify FDA's policy related to compliance with applicable performance standards and conformance to International Electrotechnical Commission (IEC) consensus standards for ultrasonic diathermy devices. This draft guidance will also provide recommendations for information to provide in 510(k) submissions for ultrasonic diathermy devices. This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 30, 2017. ADDRESSES: You may submit comments 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--Draft Guidance for Industry and Food and Drug Administration.'' 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 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 [[Page 41418]] 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. 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 ``Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices--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: 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 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 both 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. When final, this draft guidance will clarify 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 draft guidance will also provide recommendations for information to provide in 510(k) submissions for ultrasonic diathermy devices. 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 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 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 http://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 ``Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices--Draft Guidance for Industry and Food and Drug Administration'' 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 The draft guidance also 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; the collections of information in 21 CFR parts 1002 through 1050 are approved under OMB control number 0910-0025. Dated: August 28, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-18470 Filed 8-30-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices 41417
implements the electronic submission earlier versions of MedDRA will end for • Federal eRulemaking Portal:
requirements of section 745A(a) of the studies that start after March 15, 2019. https://www.regulations.gov. Follow the
Federal Food, Drug, and Cosmetic Act The FDA Data Standards Catalog will be instructions for submitting comments.
(21 U.S.C. 379k–1(a)) for study data updated to list March 15, 2019, as the Comments submitted electronically,
contained in NDAs, ANDAs, BLAs, and ‘‘date support ends.’’ Studies that start including attachments, to https://
INDs to CBER or CDER by specifying the after March 15, 2019, will be required to www.regulations.gov will be posted to
format for electronic submissions. This use the most current version of the docket unchanged. Because your
provision required that the electronic MedDRA. comment will be made public, you are
format for submission of applications be Dated: August 28, 2017. solely responsible for ensuring that your
specified in guidance and effective no comment does not include any
Leslie Kux,
sooner than 24 months after issuance of confidential information that you or a
the final guidance. The initial timetable Associate Commissioner for Policy. third party may not wish to be posted,
for the implementation of electronic [FR Doc. 2017–18471 Filed 8–30–17; 8:45 am] such as medical information, your or
submission requirements for study data BILLING CODE 4164–01–P anyone else’s Social Security number, or
is December 17, 2016 (24 months after confidential business information, such
issuance of final guidance for NDAs, as a manufacturing process. Please note
BLAs, ANDAs, and 36 months for INDs). DEPARTMENT OF HEALTH AND that if you include your name, contact
The eStudy Data guidance states that a HUMAN SERVICES information, or other information that
Federal Register notice will specify the identifies you in the body of your
Food and Drug Administration
transition date for all version updates comments, that information will be
(with the month and day for the posted on https://www.regulations.gov.
[Docket No. FDA–2017–D–4764] • If you want to submit a comment
transition date corresponding to March
15). with confidential information that you
Policy Clarification and Premarket
FDA currently supports and requires do not wish to be made available to the
Notification (510(k)) Submissions for
MedDRA for the coding of adverse public, submit the comment as a
Ultrasonic Diathermy Devices; Draft
events in studies submitted to FDA’s written/paper submission and in the
Guidance for Industry and Food and
CBER or CDER in NDAs, ANDAs, BLAs, manner detailed (see ‘‘Written/Paper
Drug Administration Staff; Availability
and INDs in the electronic common Submissions’’ and ‘‘Instructions’’).
technical document (eCTD) format. AGENCY: Food and Drug Administration,
However, the requirement to code Written/Paper Submissions
HHS.
adverse events using MedDRA in the Submit written/paper submissions as
ACTION: Notice of availability.
most current version (available at follows:
https://www.meddra.org) does not apply SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for
to postmarketing studies that are Administration (FDA or Agency) is written/paper submissions): Dockets
submitted in eCTD sections 5.3.5.4 and announcing the availability of the draft Management Staff (HFA–305), Food and
5.3.6 (https://www.fda.gov/downloads/ guidance entitled ‘‘Policy Clarification Drug Administration, 5630 Fishers
Drugs/DevelopmentApprovalProcess/ and Premarket Notification [510(k)] Lane, Rm. 1061, Rockville, MD 20852.
FormsSubmissionRequirements/ Submissions for Ultrasonic Diathermy • For written/paper comments
ElectronicSubmissions/ Devices—Draft Guidance for Industry submitted to the Dockets Management
UCM163175.pdf). and Food and Drug Administration Staff, FDA will post your comment, as
Generally, the studies included in a Staff.’’ When final, this draft guidance well as any attachments, except for
submission are conducted over many will clarify FDA’s policy related to information submitted, marked and
years and may have used different compliance with applicable identified, as confidential, if submitted
MedDRA versions to code adverse performance standards and as detailed in ‘‘Instructions.’’
events. The expectation is that sponsors conformance to International Instructions: All submissions received
or applicants will use the most current Electrotechnical Commission (IEC) must include the Docket No. FDA–
version of MedDRA at the time of study consensus standards for ultrasonic 2017–D–4764 for ‘‘Policy Clarification
start. However, there is no requirement diathermy devices. This draft guidance and Premarket Notification [510(k)]
to recode earlier studies. The transition will also provide recommendations for Submissions for Ultrasonic Diathermy
date for support and requirement to use information to provide in 510(k) Devices—Draft Guidance for Industry
the most current version of MedDRA is submissions for ultrasonic diathermy and Food and Drug Administration.’’
March 15, 2018. Although the use of the devices. This draft guidance is not final Received comments will be placed in
most current version is supported as of nor is it in effect at this time. the docket and, except for those
this Federal Register notice and submitted as ‘‘Confidential
DATES: Although you can comment on
sponsors or applicants are encouraged Submissions,’’ publicly viewable at
to begin using it, the use of the most any guidance at any time (see 21 CFR https://www.regulations.gov or at the
current version will only be required in 10.115(g)(5)), to ensure that the Agency Dockets Management Staff Office
submissions for studies that start after considers your comment of this draft between 9 a.m. and 4 p.m., Monday
March 15, 2019. The Catalog will list guidance before it begins work on the through Friday.
March 15, 2019, as the ‘‘date final version of the guidance, submit • Confidential Submissions—To
requirement begins.’’ The Study Data either electronic or written comments submit a comment with confidential
on the draft guidance by October 30, information that you do not wish to be
sradovich on DSK3GMQ082PROD with NOTICES
Technical Conformance Guide provides
additional information and 2017. made publicly available, submit your
recommendations on the coding of ADDRESSES: You may submit comments comments only as a written/paper
adverse events (https://www.fda.gov/ as follows: submission. You should submit two
downloads/forindustry/datastandards/ copies total. One copy will include the
Electronic Submissions information you claim to be confidential
studydatastandards/ucm384744.pdf).
FDA will no longer support version 8 Submit electronic comments in the with a heading or cover note that states
or earlier of MedDRA. FDA support for following way: ‘‘THIS DOCUMENT CONTAINS
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![41418 Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices
CONFIDENTIAL INFORMATION.’’ The I. Background at https://www.regulations.gov. Persons
Agency will review this copy, including Ultrasonic diathermy devices are class unable to download an electronic copy
the claimed confidential information, in II medical devices regulated under 21 of ‘‘Policy Clarification and Premarket
its consideration of comments. The CFR 890.5300(a), Ultrasonic diathermy. Notification [510(k)] Submissions for
second copy, which will have the Ultrasonic therapy devices must also Ultrasonic Diathermy Devices—Draft
claimed confidential information Guidance for Industry and Food and
comply with FDA radiation safety
redacted/blacked out, will be available Drug Administration’’ may send an
performance standards in 21 CFR part
for public viewing and posted on email request to CDRH-Guidance@
1010, Performance standards for
https://www.regulations.gov. Submit fda.hhs.gov to receive an electronic
electronic products: General, and 21
both copies to the Dockets Management copy of the document. Please use the
CFR 1050.10, Ultrasonic therapy
Staff. If you do not wish your name and document number 1500003 to identify
products. FDA recognizes that there are
contact information to be made publicly the guidance you are requesting.
several IEC standards with which other
available, you can provide this countries require conformance or IV. Paperwork Reduction Act of 1995
information on the cover sheet and not recognize for ultrasonic therapy The draft guidance also refers to
in the body of your comments and you products. This means that previously approved collections of
must identify this information as manufacturers, who distribute these information found in FDA regulations.
‘‘confidential.’’ Any information marked products in both the United States and These collections of information are
as ‘‘confidential’’ will not be disclosed other countries, might have to ensure subject to review by the Office of
except in accordance with 21 CFR 10.20 conformance of their products to IEC Management and Budget (OMB) under
and other applicable disclosure law. For standards and comply with FDA the Paperwork Reduction Act of 1995
more information about FDA’s posting performance standards. This may cause (44 U.S.C. 3501–3520). The collections
of comments to public dockets, see 80 manufacturers to duplicate their efforts. of information in 21 CFR part 807,
FR 56469, September 18, 2015, or access When final, this draft guidance will subpart E have been approved under
the information at: https://www.gpo.gov/ clarify FDA’s policy related to OMB control number 0910–0120; the
fdsys/pkg/FR-2015-09-18/pdf/2015- compliance with applicable collections of information in 21 CFR
23389.pdf. performance standards and part 801 have been approved under
conformance to IEC consensus OMB control number 0910–0485; the
Docket: For access to the docket to standards for ultrasonic diathermy collections of information in 21 CFR
read background documents or the devices. If firms provide a declaration of part 820 have been approved under
electronic and written/paper comments conformity with the relevant provisions OMB control number 0910–0073; the
received, go to https:// of the current FDA recognized versions collections of information in 21 CFR
www.regulations.gov and insert the of the IEC 60601–2–5 and IEC 61689 parts 1002 through 1050 are approved
docket number, found in brackets in the standards, FDA does not intend to under OMB control number 0910–0025.
heading of this document, into the consider whether firms comply with Dated: August 28, 2017.
‘‘Search’’ box and follow the prompts certain requirements of 21 CFR 1050.10.
Leslie Kux,
and/or go to the Dockets Management This draft guidance will also provide
Staff, 5630 Fishers Lane, Rm. 1061, Associate Commissioner for Policy.
recommendations for information to
Rockville, MD 20852. [FR Doc. 2017–18470 Filed 8–30–17; 8:45 am]
provide in 510(k) submissions for
ultrasonic diathermy devices. BILLING CODE 4164–01–P
An electronic copy of the guidance
document is available for download II. Significance of Guidance
from the internet. See the DEPARTMENT OF HEALTH AND
SUPPLEMENTARY INFORMATION section for
This draft guidance is being issued
consistent with FDA’s good guidance HUMAN SERVICES
information on electronic access to the
practices regulation (21 CFR 10.115). Food and Drug Administration
guidance. Submit written requests for a
The draft guidance, when finalized, will
single hard copy of the draft guidance [Docket No. FDA–2016–D–2153]
represent the current thinking of FDA
document entitled ‘‘Policy Clarification
on policy clarification and premarket
and Premarket Notification [510(k)] Use of Real-World Evidence To
notification (510(k)) submissions for
Submissions for Ultrasonic Diathermy Support Regulatory Decision-Making
ultrasonic diathermy devices. It does
Devices—Draft Guidance for Industry not establish any rights for any person for Medical Devices; Guidance for
and Food and Drug Administration and is not binding on FDA or the public. Industry and Food and Drug
Staff’’ to the Office of the Center You can use an alternative approach if Administration Staff; Availability
Director, Guidance and Policy it satisfies the requirements of the AGENCY: Food and Drug Administration,
Development, Center for Devices and applicable statutes and regulations. This HHS.
Radiological Health, Food and Drug guidance is not subject to Executive
Administration, 10903 New Hampshire ACTION: Notice of availability.
Order 12866.
Ave., Bldg. 66, Rm. 5431, Silver Spring, SUMMARY: The Food and Drug
MD 20993–0002. Send one self- III. Electronic Access Administration (FDA or Agency) is
addressed adhesive label to assist that Persons interested in obtaining a copy announcing the availability of the
office in processing your request. of the draft guidance may do so by guidance entitled ‘‘Use of Real-World
downloading an electronic copy from Evidence to Support Regulatory
sradovich on DSK3GMQ082PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Jismi Johnson, Center for Devices and the internet. A search capability for all Decision-Making for Medical Devices.’’
Radiological Health, Food and Drug Center for Devices and Radiological FDA is issuing this guidance to clarify
Administration, 10903 New Hampshire Health guidance documents is available how we evaluate real-world data to
at http://www.fda.gov/MedicalDevices/ determine whether it may be
Ave., Bldg. 66, Rm. 1524, Silver Spring,
DeviceRegulationandGuidance/ sufficiently relevant and reliable to
MD 20993–0002, 301–796–6424.
GuidanceDocuments/default.htm. generate the types of real-world
SUPPLEMENTARY INFORMATION: Guidance documents are also available evidence that can be used in FDA
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Document Created: 2017-09-23 10:08:32
Document Modified: 2017-09-23 10:08:32
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 30, 2017. | |
| 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 | 82 FR 41417 |
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