[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Notices]
[Pages 28876-28878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10924]
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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Technical Considerations for Additive Manufactured Devices; Draft
Guidance for Industry and Food and Drug Administration Staff;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Technical
Considerations for Additive Manufactured Devices.'' FDA has developed
this draft 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. Specifically, this draft guidance outlines
technical considerations associated with additive manufacturing
processes, and testing and characterization for final finished devices
fabricated using additive manufacturing. This draft guidance is not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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 8, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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
[[Page 28877]]
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-2016-D-1210 for ``Technical Considerations for Additive
Manufactured Devices.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management 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 http://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: http://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 http://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 draft guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the draft guidance. Submit
written requests for a single hard copy of the draft guidance document
entitled ``Technical Considerations for Additive Manufactured Devices''
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 the Office of Communication, Outreach, and
Development, Center for Biologics Evaluation and Research (CBER), 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 draft 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-wise fabrication process, and the relative
lack of medical device history of 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 (http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm397324.htm). When finalized, this
draft guidance document will recommend technical aspects of an
additively manufactured device that should be considered through the
phases of development, production process, process validation, and
final finished device testing.
This draft 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'' (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf).
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 technical
considerations for additive manufactured 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.
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 http://
www.fda.gov/MedicalDevices/
[[Page 28878]]
DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov. Persons unable to download
an electronic copy of ``Technical Considerations for Additive
Manufactured Devices'' 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
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 are approved under OMB control number 0910-
0231; the collections of information in 21 CFR part 814, subpart H are
approved under OMB control number 0910-0332; the collections of
information in 21 CFR part 807, subpart E are approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
812 are approved under OMB control number 0910-0078; the collections of
information in 21 CFR part 820 are approved under OMB control number
0910-0073; the collections of information in 21 CFR parts 801 and 809
are approved under OMB control number 0910-0485; and the collections of
information in the guidance document entitled ``Requests for Feedback
on Medical Device Submissions: The Pre-Submission Program and Meetings
with Food and Drug Administration Staff'' are approved under OMB
control number 0910-0756.
Dated: May 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10924 Filed 5-9-16; 8:45 am]
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