[Federal Register Volume 79, Number 96 (Monday, May 19, 2014)]
[Notices]
[Pages 28732-28733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-11513]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0432]


Additive Manufacturing of Medical Devices: An Interactive 
Discussion on the Technical Considerations of 3-D Printing; Public 
Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``Additive Manufacturing of Medical Devices: 
An Interactive Discussion on the Technical Considerations of 3-D 
Printing.'' The purpose of this workshop is to provide a forum for FDA, 
medical device manufactures, additive manufacturing companies, and 
academia to discuss technical challenges and solutions of 3-D printing. 
The Agency would like input regarding technical assessments that should 
be considered for additively manufactured devices to provide a 
transparent evaluation process for future submissions.
    Dates and Times: The public workshop will be held on October 8 and 
9, 2014, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the FDA's White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public 
workshop participants (non-FDA employees) is through Building 1 where 
routine security check procedures will be performed. For parking and 
security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: 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, 301-796-2507, email: 
[email protected].
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by September 30, 2014, 4 p.m. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. If time and space permits, onsite registration on the day 
of the public workshop will be provided beginning at 7 a.m.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4321, 
Silver Spring, MD 20993-0002, 301-796-5661, email: 
[email protected] no later than September 23, 2014.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events-Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select the appropriate public workshop from the events list). Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone number. Those without 
Internet access should contact Susan Monahan to register (see 
Registration). Registrants will receive confirmation after they have 
been accepted and will be notified if they are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. Persons interested in viewing the Webcast must 
register online by September 30, 2014, 4 p.m. Early registration is 
recommended because Webcast connections are limited. Organizations are 
requested to register all participants, but to view using one 
connection per location. Webcast participants will be sent technical 
system requirements after registration and will be sent connection 
access information after October 1, 2014. If you have never attended a 
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get 
a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site 
addresses in this document, but FDA is not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)
    Comments: FDA is holding this public workshop to obtain information 
on the technical challenges of additively manufacturing medical 
devices. In order to permit the widest possible opportunity to obtain 
public comment, FDA is soliciting either electronic or written comments 
on all aspects of the public workshop topics. The deadline for 
submitting comments related to this public workshop is November 10, 
2014.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments to http://www.regulations.gov or 
written comments to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. In addition, when responding to specific questions as 
outlined in section II of this document, please identify the question 
you are addressing. Received comments may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (see Comments). A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. A link to the transcripts will also be available 
approximately 45 days after the public workshop on the Internet at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

SUPPLEMENTARY INFORMATION:

I. Background

    Additive manufacturing, also known as 3-D printing, is a fast-
growing manufacturing technique that builds devices from computerized 
blueprints or models, by layering material only where it is needed as 
if building with interlocking bricks. Traditional methods of 
manufacturing remove material from larger pieces by cutting, drilling, 
and carving to create a final part. Through additive manufacturing 
designers can alter products quickly for rapid prototype iteration or 
produce small batches of multiple product designs in each batch. The 3-
D computer models used to build each part can be created using 
traditional computer aided design techniques or they can be made 
directly from 3-D image sources, such as computed tomography scans or 
magnetic resonance imaging. Designers can also use a combination of 
techniques. Consequently, 3-D printers can create truly anatomically 
matched

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devices or surgical guides by utilizing a patient's own medical 
imaging.
    Additive manufacturing is just beginning to enter mainstream use in 
medical devices. This technology unlocks new avenues for creativity and 
innovation for medical device designers. For example, it can facilitate 
the production of devices with intricate structures that were 
previously impractical or impossible. Current industry applications 
include using it as an alternative device production method for 
traditional components or as a primary method to create patient-matched 
devices. As the technology matures, additional capabilities may be 
incorporated into medical devices. FDA has begun to receive submissions 
using additive manufacturing for both traditional and patient-matched 
devices, and we see many more on the horizon. Industry forecasts 
project significant growth of additive manufacturing in both 
traditional and innovative environments by 2025.
    Additive manufacturing may or may not present new questions 
depending on its use. However, there are technical challenges 
associated with the process from design to final product that need to 
be properly addressed in all cases to ensure patient safety and to 
promote innovation in a fast-moving field. Process verification and 
validation are especially important when devices are produced 
individually or in very small batches. By discussing and addressing 
these technical challenges through an open forum, FDA would like to 
foster innovation with a transparent process and shared expectations 
for stakeholders. Participants in the workshop will include 
researchers, scientists, and engineers involved with the research and 
development of products using additive manufacturing as one or more 
steps of the manufacturing process. The intent is to address scientific 
and technical challenges posed by additive manufacturing process but 
not address specific printing technologies or medical device types. The 
latter will still be covered by their respective standards and guidance 
documents. Ideas generated during this workshop may facilitate 
development of new draft guidances and/or standards for additive 
manufacturing of medical devices.

II. Topics for Discussion at the Public Workshop

    At this public workshop, participants will engage in open dialogue 
and discuss the following factors that contribute to additively 
manufactured medical devices.
     Preprinting considerations, including but not limited to:
    [cir] material chemistry;
    [cir] physical properties;
    [cir] recyclability;
    [cir] part reproducibility; and
    [cir] process validation.
     Printing considerations, including but not limited to:
    [cir] printing process characterization;
    [cir] software used in the process;
    [cir] post-processing steps (hot isostatic pressing, curing); and
    [cir] additional machining.
     Post-printing considerations, including but not limited 
to:
    [cir] cleaning/excess material removal;
    [cir] effect of complexity on sterilization and biocompatibility;
    [cir] final device mechanics;
    [cir] design envelope; and
    [cir] verification.
    This is not an inclusive list. There will be discussion time and 
breakout sessions to bring up topics that are not listed.
    The goals of the public workshop are to:
     Develop a more complete understanding of the technical 
challenges and solutions in additive manufacturing across a variety of 
materials and printing technologies that will affect safety and 
effectiveness of medical devices;
     Create awareness of these technical challenges and 
collaboratively develop solutions and best practices to ensure the 
performance and reliability of these devices; create a forum for open 
dialogue among stakeholders to share lessons learned and best practices 
for overcoming the technical challenges presented by additive 
manufacturing;
     Promote innovation in technology and processes to ensure 
and improve device performance and reliability; and
     Coordinate future collaborations in the development of 
educational materials, standards, and guidance.

    Dated: May 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11513 Filed 5-16-14; 8:45 am]
BILLING CODE 4160-01-P