81 FR 28876 - Technical Considerations for Additive Manufactured Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 90 (May 10, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Technical Considerations for Additive Manufactured Devices.''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 Specifically, this draft guidance outlines technical considerations associated with additive manufacturing processes, and testing and characterization for final finished devices fabricated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 This draft guidance is not final nor is it in effect at this time.

[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Notices]
[Pages 28876-28878]
From the Federal Register Online  [www.thefederalregister.org]
[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Technical Considerations for Additive Manufactured Devices; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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the availability of the draft guidance entitled ``Technical 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 Specifically, this draft guidance outlines 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 This draft guidance is not 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draft guidance before it begins work on the final version of the 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]
BILLING CODE 4164-01-P