[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]
[[Page 28732]]
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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