[Federal Register Volume 82, Number 232 (Tuesday, December 5, 2017)]
[Notices]
[Pages 57462-57463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26196]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1210]


Technical Considerations for Additive Manufactured Medical 
Devices; 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 the guidance entitled ``Technical Considerations 
for Additive Manufactured Medical Devices; Guidance for Industry and 
Food and Drug Administration Staff.'' FDA has developed this leapfrog 
guidance to provide FDA's initial thoughts on technical considerations 
specific to devices using additive manufacturing, the broad category of 
manufacturing encompassing 3-dimensional (3D) printing. This guidance 
outlines technical considerations associated with additive 
manufacturing processes as well as testing and characterization for 
final finished devices fabricated using additive manufacturing.

DATES: The announcement of the guidance is published in the Federal 
Register on December 5, 2017.

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-2016-D-1210 for ``Technical Considerations for Additive 
Manufactured Medical Devices; Guidance for Industry and Food and Drug 
Administration Staff; Availability.'' 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

[[Page 57463]]

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 
``Technical Considerations for Additive Manufactured Devices; 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: Matthew Di Prima, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 62, Rm. 2214, Silver Spring, MD 20993-0002, 301-
796-2507 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

    FDA has developed this leapfrog guidance to provide FDA's initial 
thoughts on technical considerations specific to devices using additive 
manufacturing (AM), the broad category of manufacturing encompassing 3D 
printing. In medical device applications, AM has the advantage of 
facilitating the creation of anatomically-matched devices and surgical 
instrumentation by using a patient's own medical imaging. Another 
advantage is the ease in fabricating complex geometric structures, 
allowing the creation of engineered open lattice structures, tortuous 
internal channels, and internal support structures that would not be 
easily possible using traditional (non-additive) manufacturing 
approaches. However, the unique aspects of the AM process, such as the 
layer-by-layer fabrication process, and the relative lack of experience 
and clinical history of with respect to devices manufactured using AM 
techniques, pose challenges in determining optimal characterization and 
assessment methods for the final finished device, as well as optimal 
process validation and verification methods for these devices. To 
discuss these challenges and obtain initial stakeholder input, the FDA 
held a public workshop entitled ``Additive Manufacturing of Medical 
Devices: An Interactive Discussion on the Technical Considerations of 
3D Printing,'' on October 8-9, 2014 (79 FR 28732).
    This guidance is a leapfrog guidance; leapfrog guidances are 
intended to serve as a mechanism by which the Agency can share initial 
thoughts regarding the content of premarket submissions for emerging 
technologies and new clinical applications that are likely to be of 
public health importance very early in product development. This 
leapfrog guidance represents the Agency's initial thinking, and our 
recommendations may change as more information becomes available. The 
Agency strongly encourages manufacturers to engage with CDRH and/or 
CBER through the Pre-Submission process to obtain more detailed 
feedback regarding their AM device or process. For more information on 
Pre-Submissions, please see ``Requests for Feedback on Medical Device 
Submissions: The Pre-Submission Program and Meetings with Food and Drug 
Administration Staff'' (https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf).
    The FDA considered comments received on the draft guidance that 
appeared in the Federal Register of May 10, 2016 (81 FR 28876). FDA has 
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 ``Technical Considerations for Additive 
Manufactured Medical 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 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.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download 
an electronic copy of ``Technical Considerations for Additive 
Manufactured Medical Devices; 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 1400002 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This 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 801 have been approved under 
OMB control number 0910-0485; 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 812 have been 
approved under OMB control number 0910-0078; the collections of 
information in 21 CFR part 814, subparts A through 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. The collections of 
information in the guidance document ``Requests for Feedback on Medical 
Device Submissions: The Pre-Submission Program and Meetings with Food 
and Drug Administration Staff'' have been approved under OMB control 
number 0910-0756.

    Dated: November 30, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26196 Filed 12-4-17; 8:45 am]
 BILLING CODE 4164-01-P