Manufacturing Site Change Supplements: Content and Submission; Guidance for Industry and Food and Drug Administration Staff; Availability, 64582-64584 [2018-27237]
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64582
Federal Register / Vol. 83, No. 241 / Monday, December 17, 2018 / Notices
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Instrument
ORR–9 (Annual Survey of Refugees) .................................
Pre-survey information form ................................................
Estimated Total Annual Burden
Hours: 1,100.
Authority: Sec. 413.[8 U.S.C. 1523].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–27235 Filed 12–14–18; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3454]
Manufacturing Site Change
Supplements: Content and
Submission; 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 a final
guidance entitled ‘‘Manufacturing Site
Change Supplements: Content and
Submissions; Guidance for Industry and
Food and Drug Administration Staff.’’
This guidance describes the decisionmaking steps that FDA recommends to
determine whether a premarket
approval application (PMA) supplement
should be submitted when a
manufacturer intends to change the
manufacturing site (including a change
to the processing, packaging, or
sterilization site) of its legally marketed
PMA-approved device. This guidance
also discusses the general factors FDA
intends to consider when determining
whether to conduct an establishment
inspection prior to approval of a site
change supplement.
DATES: The announcement of the
guidance is published in the Federal
Register on December 17, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
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19:17 Dec 14, 2018
Jkt 247001
Annual
number of
respondents
6000
6000
2000
2000
• 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–
2015–N–3454 for ‘‘Manufacturing Site
Change Supplements: Content and
Submission; 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 between 9
a.m. and 4 p.m., Monday through
Friday.
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
Average
burden
hours per
response
0.5
0.05
Annual burden
hours
1000
100
• 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/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.
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 ‘‘Manufacturing Site
E:\FR\FM\17DEN1.SGM
17DEN1
Federal Register / Vol. 83, No. 241 / Monday, December 17, 2018 / Notices
Change Supplements: Content and
Submissions: 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; or the Office of Communication,
Outreach, and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
request.
FOR FURTHER INFORMATION CONTACT:
Bleta Vuniqi, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3463, Silver Spring,
MD 20993–0002, 301–796–5497.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 515(d)(6) of the Federal
Food, Drug and Cosmetic Act (21 U.S.C.
360e(d)(6)), a PMA supplement must be
submitted for review and approval by
FDA before making a change that affects
the device’s safety or effectiveness,
unless such change is a modification in
a manufacturing procedure or method of
manufacture, which would be eligible
for a 30-day notice. The PMA
regulations provide general criteria in
21 CFR 814.39 for determining when
PMA holders are required to submit a
PMA supplement or are eligible to
submit a 30-day notice.
This guidance document explains: (1)
What constitutes a manufacturing site
change and when a manufacturer
should submit a PMA supplement for a
site change; (2) what documentation a
manufacturer should submit in the site
change supplement; and (3) the general
factors that FDA intends to consider
when determining whether to conduct
an establishment inspection prior to the
approval of a site change supplement.
This guidance is intended to help
industry decide when a change in
manufacturing site should be submitted
in a PMA site change supplement. This
guidance is also intended to help
industry predict when a preapproval
inspection in connection with a PMA
supplement for a manufacturing site
change will likely be needed to evaluate
the firm’s implementation of Quality
System regulation requirements, 21 CFR
part 820. As a result, this guidance
should help manufacturers manage the
timeframes associated with
implementing the changes in the
manufacturing site and any processes,
methods, procedures, qualifications,
and validations.
Please note that this guidance only
applies to a manufacturer of a device
with an approved PMA, a product
development protocol, or a
humanitarian device exemption. This
guidance does not address
manufacturing site changes for devices
cleared under the premarket notification
(510(k)) submissions, granted premarket
authorization through the De Novo
pathway, or approved and distributed as
part of an investigational device
exemption.
FDA considered comments received
on the draft guidance that appeared in
the Federal Register of October 21,
2015. 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 ‘‘Manufacturing Site
Change Supplements: Content and
Submission; Guidance for Industry and
Food and Drug Administration Staff.’’ 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.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/default.htm or
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Manufacturing Site Change
Supplements: Content and Submissions;
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 1269 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 or guidance have been
approved by OMB as listed in the
following table.
21 CFR part or guidance
Topic
814, subparts A through E .......................................................
814, subpart H .........................................................................
‘‘Requests for Feedback on Medical Device Submissions:
The Pre-Submission Program and Meetings with Food and
Drug Administration Staff’’.
820 ...........................................................................................
Premarket Approval ................................................................
Humanitarian Device Exemption .............................................
Q-Submissions ........................................................................
0910–0231
0910–0332
0910–0756
Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.
Electronic Submission of Medical Device Registration and
Listing.
0910–0073
807, subparts A through D ......................................................
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OMB control No.
17DEN1
0910–0625
64584
Federal Register / Vol. 83, No. 241 / Monday, December 17, 2018 / Notices
Dated: December 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–27237 Filed 12–14–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–4115]
Clarification of Radiation Control
Regulations for Manufacturers of
Diagnostic X-Ray Equipment; 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 ‘‘Clarification of
Radiation Control Regulations for
Manufacturers of Diagnostic X-Ray
Equipment.’’ This draft guidance
provides clarification to industry and
FDA staff of the Federal regulations that
relate to diagnostic x-ray systems and
their major components. These
regulations pertain to the recordkeeping,
reporting, manufacturing, importing,
and installation of ‘‘electronic
products,’’ as defined in FDA
regulations. This draft guidance, when
finalized, will supersede FDA’s
guidance entitled ‘‘Clarification of
Radiation Control Regulations for
Diagnostic X-Ray Equipment.’’ This
draft guidance is not final nor is it in
effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by February 15, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
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,
VerDate Sep<11>2014
19:17 Dec 14, 2018
Jkt 247001
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–
2018–D–4115 for ‘‘Clarification of
Radiation Control Regulations for
Manufacturers of Diagnostic X-Ray
Equipment.’’ 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
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
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.
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 draft guidance
document entitled ‘‘Clarification of
Radiation Control Regulations for
Manufacturers of Diagnostic X-Ray
Equipment’’ 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:
Scott Gonzalez, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4276, Silver Spring,
MD 20993–0002, 301–796–5889.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance provides
clarification to industry and FDA staff of
the Federal regulations that relate to
diagnostic x-ray systems and their major
components. The Federal Food, Drug,
and Cosmetic Act (FD&C Act) defines
diagnostic x-ray systems as both a
medical device, under section 201(h) of
the FD&C Act (21 U.S.C. 321(h)), and an
electronic product, under section 531 of
the FD&C Act (21 U.S.C. 360hh). As
such, these devices are subject to the
provisions of the FD&C Act that apply
to medical devices (e.g., sections 510
E:\FR\FM\17DEN1.SGM
17DEN1
]]>Agencies
[Federal Register Volume 83, Number 241 (Monday, December 17, 2018)]
[Notices]
[Pages 64582-64584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27237]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3454]
Manufacturing Site Change Supplements: Content and Submission;
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 a final guidance entitled ``Manufacturing Site
Change Supplements: Content and Submissions; Guidance for Industry and
Food and Drug Administration Staff.'' This guidance describes the
decision-making steps that FDA recommends to determine whether a
premarket approval application (PMA) supplement should be submitted
when a manufacturer intends to change the manufacturing site (including
a change to the processing, packaging, or sterilization site) of its
legally marketed PMA-approved device. This guidance also discusses the
general factors FDA intends to consider when determining whether to
conduct an establishment inspection prior to approval of a site change
supplement.
DATES: The announcement of the guidance is published in the Federal
Register on December 17, 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-2015-N-3454 for ``Manufacturing Site Change Supplements: Content
and Submission; 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 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
``Manufacturing Site
[[Page 64583]]
Change Supplements: Content and Submissions: 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; or the Office
of Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.
FOR FURTHER INFORMATION CONTACT: Bleta Vuniqi, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3463, Silver Spring, MD 20993-0002, 301-796-5497.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 515(d)(6) of the Federal Food, Drug and Cosmetic Act
(21 U.S.C. 360e(d)(6)), a PMA supplement must be submitted for review
and approval by FDA before making a change that affects the device's
safety or effectiveness, unless such change is a modification in a
manufacturing procedure or method of manufacture, which would be
eligible for a 30-day notice. The PMA regulations provide general
criteria in 21 CFR 814.39 for determining when PMA holders are required
to submit a PMA supplement or are eligible to submit a 30-day notice.
This guidance document explains: (1) What constitutes a
manufacturing site change and when a manufacturer should submit a PMA
supplement for a site change; (2) what documentation a manufacturer
should submit in the site change supplement; and (3) the general
factors that FDA intends to consider when determining whether to
conduct an establishment inspection prior to the approval of a site
change supplement. This guidance is intended to help industry decide
when a change in manufacturing site should be submitted in a PMA site
change supplement. This guidance is also intended to help industry
predict when a preapproval inspection in connection with a PMA
supplement for a manufacturing site change will likely be needed to
evaluate the firm's implementation of Quality System regulation
requirements, 21 CFR part 820. As a result, this guidance should help
manufacturers manage the timeframes associated with implementing the
changes in the manufacturing site and any processes, methods,
procedures, qualifications, and validations.
Please note that this guidance only applies to a manufacturer of a
device with an approved PMA, a product development protocol, or a
humanitarian device exemption. This guidance does not address
manufacturing site changes for devices cleared under the premarket
notification (510(k)) submissions, granted premarket authorization
through the De Novo pathway, or approved and distributed as part of an
investigational device exemption.
FDA considered comments received on the draft guidance that
appeared in the Federal Register of October 21, 2015. 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 ``Manufacturing Site Change Supplements:
Content and Submission; Guidance for Industry and Food and Drug
Administration Staff.'' 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.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download
an electronic copy of ``Manufacturing Site Change Supplements: Content
and Submissions; 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 1269 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 or guidance have been approved by OMB as
listed in the following table.
------------------------------------------------------------------------
21 CFR part or guidance Topic OMB control No.
------------------------------------------------------------------------
814, subparts A through E....... Premarket Approval. 0910-0231
814, subpart H.................. Humanitarian Device 0910-0332
Exemption.
``Requests for Feedback on Q-Submissions...... 0910-0756
Medical Device Submissions: The
Pre-Submission Program and
Meetings with Food and Drug
Administration Staff''.
820............................. Current Good 0910-0073
Manufacturing
Practice (CGMP);
Quality System
(QS) Regulation.
807, subparts A through D....... Electronic 0910-0625
Submission of
Medical Device
Registration and
Listing.
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[[Page 64584]]
Dated: December 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-27237 Filed 12-14-18; 8:45 am]
BILLING CODE 4164-01-P
