Policy Clarification and Premarket Notification (510(k)) Submissions for Ultrasonic Diathermy Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 41417-41418 [2017-18470]
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sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices
implements the electronic submission
requirements of section 745A(a) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379k–1(a)) for study data
contained in NDAs, ANDAs, BLAs, and
INDs to CBER or CDER by specifying the
format for electronic submissions. This
provision required that the electronic
format for submission of applications be
specified in guidance and effective no
sooner than 24 months after issuance of
the final guidance. The initial timetable
for the implementation of electronic
submission requirements for study data
is December 17, 2016 (24 months after
issuance of final guidance for NDAs,
BLAs, ANDAs, and 36 months for INDs).
The eStudy Data guidance states that a
Federal Register notice will specify the
transition date for all version updates
(with the month and day for the
transition date corresponding to March
15).
FDA currently supports and requires
MedDRA for the coding of adverse
events in studies submitted to FDA’s
CBER or CDER in NDAs, ANDAs, BLAs,
and INDs in the electronic common
technical document (eCTD) format.
However, the requirement to code
adverse events using MedDRA in the
most current version (available at
https://www.meddra.org) does not apply
to postmarketing studies that are
submitted in eCTD sections 5.3.5.4 and
5.3.6 (https://www.fda.gov/downloads/
Drugs/DevelopmentApprovalProcess/
FormsSubmissionRequirements/
ElectronicSubmissions/
UCM163175.pdf).
Generally, the studies included in a
submission are conducted over many
years and may have used different
MedDRA versions to code adverse
events. The expectation is that sponsors
or applicants will use the most current
version of MedDRA at the time of study
start. However, there is no requirement
to recode earlier studies. The transition
date for support and requirement to use
the most current version of MedDRA is
March 15, 2018. Although the use of the
most current version is supported as of
this Federal Register notice and
sponsors or applicants are encouraged
to begin using it, the use of the most
current version will only be required in
submissions for studies that start after
March 15, 2019. The Catalog will list
March 15, 2019, as the ‘‘date
requirement begins.’’ The Study Data
Technical Conformance Guide provides
additional information and
recommendations on the coding of
adverse events (https://www.fda.gov/
downloads/forindustry/datastandards/
studydatastandards/ucm384744.pdf).
FDA will no longer support version 8
or earlier of MedDRA. FDA support for
VerDate Sep<11>2014
20:54 Aug 30, 2017
Jkt 241001
earlier versions of MedDRA will end for
studies that start after March 15, 2019.
The FDA Data Standards Catalog will be
updated to list March 15, 2019, as the
‘‘date support ends.’’ Studies that start
after March 15, 2019, will be required to
use the most current version of
MedDRA.
Dated: August 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–18471 Filed 8–30–17; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
ADDRESSES:
You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
41417
• 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
E:\FR\FM\31AUN1.SGM
31AUN1
41418
Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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/201523389.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 selfaddressed 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:
VerDate Sep<11>2014
20:54 Aug 30, 2017
Jkt 241001
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.
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 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
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
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.
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
Frm 00028
Fmt 4703
Food and Drug Administration
[Docket No. FDA–2016–D–2153]
Use of Real-World Evidence To
Support Regulatory Decision-Making
for Medical Devices; Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the
guidance entitled ‘‘Use of Real-World
Evidence to Support Regulatory
Decision-Making for Medical Devices.’’
FDA is issuing this guidance to clarify
how we evaluate real-world data to
determine whether it may be
sufficiently relevant and reliable to
generate the types of real-world
evidence that can be used in FDA
SUMMARY:
III. Electronic Access
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sfmt 4703
E:\FR\FM\31AUN1.SGM
31AUN1
Agencies
[Federal Register Volume 82, Number 168 (Thursday, August 31, 2017)]
[Notices]
[Pages 41417-41418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.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.
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 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 ``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 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
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