Manufacturing Site Change Supplements: Content and Submission; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 63802-63804 [2015-26637]
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63802
Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Type of respondent
Activity
LGBT young adults aged
18–24 in the select media
markets—Recruited via
social media (30% combined eligibility and response rate).
Media tracking screeners ....
LGBT young adults aged
18–24 in the select media
markets—Recruited via
social media (30% combined eligibility and response rate).
Media tracking questionnaires.
Screener—First media
tracking.
Screener—Second media
tracking.
Screener—Third media
tracking.
.............................................
Questionnaire—First media
tracking.
Questionnaire—Second
media tracking.
Questionnaire—Third media
tracking.
.............................................
Total media tracking
(screeners and questionnaires).
Totals Across All
Study Components.
1 There
Total annual
hours
556
1
556
0.083
46
556
1
556
0.083
46
556
1,668
1
........................
556
1,668
0.083
........................
46
138
167
0.667
111
167
167
0.667
111
167
501
1
........................
167
501
0.667
........................
111
333
.............................................
2,169
........................
2,169
........................
471
.............................................
15,288
........................
15,288
........................
3,839
are no capital costs or operating and maintenance costs associated with this collection of information.
intends to consider to determine
whether a preapproval inspection is
necessary before approval of the PMA
supplement. This draft guidance is not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considers your comment of this draft
guidance before it begins work on the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on the draft guidance by January 19,
2016.
ADDRESSES: You may submit comments
as follows:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3454]
Manufacturing Site Change
Supplements: Content and
Submission; Draft Guidance for
Industry and Food and Drug
Administration Staff; Availability
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Manufacturing Site Change
Supplements: Content and
Submission’’. This draft 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
SUMMARY:
tkelley on DSK3SPTVN1PROD with NOTICES
Average
burden per
response
(in hours)
1
[FR Doc. 2015–26671 Filed 10–20–15; 8:45 am]
ACTION:
Total annual
responses
167
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Number of
responses per
respondent
VerDate Sep<11>2014
22:39 Oct 20, 2015
Jkt 238001
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
PO 00000
Frm 00066
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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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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.’’ 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
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
E:\FR\FM\21OCN1.SGM
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tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
• 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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 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 ‘‘Manufacturing Site
Change Supplements: Content and
Submission’’ to the Office of the Center
Director, Guidance and Policy
Development, Center for Devices and
Radiological Health (CDRH), Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993–0002; or to the
Office of Communication, Outreach, and
Development, Center for Biologics
Evaluation and Research (CBER), 10903
New Hampshire Ave., Bldg. 71, Rm.
3103, Silver Spring, MD 20993–0002.
VerDate Sep<11>2014
22:39 Oct 20, 2015
Jkt 238001
Send one self-addressed adhesive label
to assist that office in processing your
request, or fax your request to 301–847–
8149.
FOR FURTHER INFORMATION CONTACT:
William MacFarland, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Silver Spring, MD
20993–0002, 301–796–5547; or Stephen
Ripley, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993, 240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 515(d)(6) of the Federal
Food, Drug, and Cosmetic Act (the
FD&C 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
§ 814. 39 (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.
Pursuant to § 814.39(a)(3), a PMA holder
must submit a PMA supplement for
review and approval by FDA concerning
the ‘‘use of a different facility or
establishment to manufacture, process,
or package the device’’ that affects the
safety or effectiveness of a device before
implementing the change. With respect
to establishment inspections, section
510(h) of the FD&C Act (21 U.S.C.
360(h)) requires every registered
establishment to be subject to
inspections pursuant to section 704 of
the FD&C Act (21 U.S.C. 374) and to be
inspected at least once in the 2-year
period after registration and at least
once in every successive 2-year period
thereafter.
In March 1996, CDRH sent a letter to
the medical device industry that
announced a 1-year pilot program to
improve the processing of PMA
supplements for changes in
manufacturing sites. The letter
discussed the need to improve the speed
and efficiency of CDRH review and
approval of manufacturing site change
supplements, and stated that CDRH did
not require preapproval inspection for
all site changes. CDRH later developed
the draft guidance entitled ‘‘Likelihood
of Facilities Inspections When
Modifying Devices Subject to Premarket
Approval,’’ which was issued on August
PO 00000
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Fmt 4703
Sfmt 4703
63803
5, 1999. This guidance was never
finalized.
The PMA supplements described in
the March 1996 letter and the 1999 draft
guidance were called ‘‘site change
supplements’’ or, if no preapproval
inspection was required, they were
termed ‘‘express supplements.’’ FDA
now identifies all such submissions as
‘‘site change supplements’’ with a
designation of whether or not an
inspection is needed before the change
can be implemented. Based on feedback
from industry and the Agency’s
experience over many years, FDA has
made substantial revisions and updates
to the 1999 draft guidance and is
reissuing it for comment as this Level 1
draft guidance.
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
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. The
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 premarket notification
(510(k)) submissions.
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 manufacturing site change
supplements’ content and submission. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
E:\FR\FM\21OCN1.SGM
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63804
Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
approach if it satisfies the requirements
of the applicable statutes and
regulations.
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
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov or from
CBER at https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/default.htm.
Persons unable to download an
electronic copy of ‘‘Manufacturing Site
Change Supplements: Content and
Submission’’ 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 draft 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 814,
subparts B and E have been approved
under OMB control number 0910–0231;
the collections of information in 21 CFR
part 814, subpart H have been approved
under OMB control number 0910–0332;
and the collections of information in 21
CFR part 820 have been approved under
OMB control number 0910–0073.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Administrative Practices and
Procedures; Formal Evidentiary Public
Hearing’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUMMARY:
On May
12, 2015, the Agency submitted a
proposed collection of information
entitled ‘‘Administrative Practices and
Procedures; Formal Evidentiary Public
Hearing’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0191. The
approval expires on September 30,
2018. A copy of the supporting
statement for this information collection
is available on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26639 Filed 10–20–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2015–26637 Filed 10–20–15; 8:45 am]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Center for Devices
and Radiological Health Appeals
Processes
[Docket No. FDA–2011–D–0893]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration
Food and Drug Administration,
Notice.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Administrative Practices and
Procedures; Formal Evidentiary Public
Hearing
SUMMARY:
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
22:39 Oct 20, 2015
Jkt 238001
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
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
HHS.
[Docket No. FDA–2014–N–2029]
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
information collection associated with
the processes available to outside
stakeholders to request additional
review of decisions or actions by Center
for Devices and Radiological Health
(CDRH) employees.
DATES: Submit either electronic or
written comments on the collection of
information by December 21, 2015.
ADDRESSES: You may submit comments
as follows:
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2011–D–0893] for Agency Information
E:\FR\FM\21OCN1.SGM
21OCN1
]]>Agencies
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Pages 63802-63804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26637]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-3454]
Manufacturing Site Change Supplements: Content and Submission;
Draft Guidance for Industry and Food and Drug Administration Staff;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Manufacturing Site Change
Supplements: Content and Submission''. This draft 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 to determine whether a
preapproval inspection is necessary before approval of the PMA
supplement. 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 January 19, 2016.
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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.'' 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 Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
[[Page 63803]]
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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 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
``Manufacturing Site Change Supplements: Content and Submission'' to
the Office of the Center Director, Guidance and Policy Development,
Center for Devices and Radiological Health (CDRH), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002; or to the Office of Communication, Outreach, and
Development, Center for Biologics Evaluation and Research (CBER), 10903
New Hampshire Ave., Bldg. 71, Rm. 3103, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to 301-847-8149.
FOR FURTHER INFORMATION CONTACT: William MacFarland, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002, 301-796-5547;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 515(d)(6) of the Federal Food, Drug, and Cosmetic Act
(the FD&C 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 Sec. 814. 39 (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. Pursuant to Sec. 814.39(a)(3),
a PMA holder must submit a PMA supplement for review and approval by
FDA concerning the ``use of a different facility or establishment to
manufacture, process, or package the device'' that affects the safety
or effectiveness of a device before implementing the change. With
respect to establishment inspections, section 510(h) of the FD&C Act
(21 U.S.C. 360(h)) requires every registered establishment to be
subject to inspections pursuant to section 704 of the FD&C Act (21
U.S.C. 374) and to be inspected at least once in the 2-year period
after registration and at least once in every successive 2-year period
thereafter.
In March 1996, CDRH sent a letter to the medical device industry
that announced a 1-year pilot program to improve the processing of PMA
supplements for changes in manufacturing sites. The letter discussed
the need to improve the speed and efficiency of CDRH review and
approval of manufacturing site change supplements, and stated that CDRH
did not require preapproval inspection for all site changes. CDRH later
developed the draft guidance entitled ``Likelihood of Facilities
Inspections When Modifying Devices Subject to Premarket Approval,''
which was issued on August 5, 1999. This guidance was never finalized.
The PMA supplements described in the March 1996 letter and the 1999
draft guidance were called ``site change supplements'' or, if no
preapproval inspection was required, they were termed ``express
supplements.'' FDA now identifies all such submissions as ``site change
supplements'' with a designation of whether or not an inspection is
needed before the change can be implemented. Based on feedback from
industry and the Agency's experience over many years, FDA has made
substantial revisions and updates to the 1999 draft guidance and is
reissuing it for comment as this Level 1 draft guidance.
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 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. The 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 premarket
notification (510(k)) submissions.
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 manufacturing
site change supplements' content and submission. It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative
[[Page 63804]]
approach if it satisfies the requirements of the applicable statutes
and regulations.
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 CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
https://www.regulations.gov or from CBER at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to download an electronic copy of
``Manufacturing Site Change Supplements: Content and Submission'' 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 draft 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 814, subparts B and E have
been approved under OMB control number 0910-0231; the collections of
information in 21 CFR part 814, subpart H have been approved under OMB
control number 0910-0332; and the collections of information in 21 CFR
part 820 have been approved under OMB control number 0910-0073.
Dated: October 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-26637 Filed 10-20-15; 8:45 am]
BILLING CODE 4164-01-P
