[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]


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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.

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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 [email protected] 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.

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     21 CFR part or guidance             Topic          OMB control No.
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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