82 FR 57462 - Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 232 (December 5, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 232 (December 5, 2017)
| Page Range | 57462-57463 | |
| FR Document | 2017-26196 |
[Federal Register Volume 82, Number 232 (Tuesday, December 5, 2017)] [Notices] [Pages 57462-57463] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26196] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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.thefederalregister.org/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
![57462 Federal Register / Vol. 82, No. 232 / Tuesday, December 5, 2017 / Notices
use the document number 1500074 to Manufactured Medical Devices; identified, as confidential, if submitted
identify the guidance you are Guidance for Industry and Food and as detailed in ‘‘Instructions.’’
requesting. Drug Administration Staff.’’ FDA has Instructions: All submissions received
developed this leapfrog guidance to must include the Docket No. FDA–
IV. Paperwork Reduction Act of 1995 2016–D–1210 for ‘‘Technical
provide FDA’s initial thoughts on
This guidance refers to previously technical considerations specific to Considerations for Additive
approved collections of information devices using additive manufacturing, Manufactured Medical Devices;
found in FDA and CMS regulations. the broad category of manufacturing Guidance for Industry and Food and
These collections of information are encompassing 3-dimensional (3D) Drug Administration Staff;
subject to review by the Office of printing. This guidance outlines Availability.’’ Received comments will
Management and Budget (OMB) under technical considerations associated with be placed in the docket and, except for
the Paperwork Reduction Act of 1995 additive manufacturing processes as those submitted as ‘‘Confidential
(44 U.S.C. 3501–3520). The collections well as testing and characterization for Submissions,’’ publicly viewable at
of information in 21 CFR part 812 have final finished devices fabricated using https://www.regulations.gov or at the
been approved under OMB control additive manufacturing. Dockets Management Staff between 9
number 0910–0078. The collections of DATES: The announcement of the
a.m. and 4 p.m., Monday through
information in 42 CFR part 405, subpart guidance is published in the Federal Friday.
B have been approved under OMB • Confidential Submissions—To
Register on December 5, 2017.
control number 0938–1250. submit a comment with confidential
ADDRESSES: You may submit either information that you do not wish to be
V. Reference electronic or written comments on made publicly available, submit your
The following reference is on display Agency guidances at any time as comments only as a written/paper
in the Dockets Management Staff (see follows: submission. You should submit two
ADDRESSES) and is available for viewing Electronic Submissions copies total. One copy will include the
by interested persons between 9 a.m. information you claim to be confidential
and 4 p.m., Monday through Friday; it Submit electronic comments in the with a heading or cover note that states
is also available electronically at https:// following way: ‘‘THIS DOCUMENT CONTAINS
www.regulations.gov. FDA has verified • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
the Web site address, as of the date this https://www.regulations.gov. Follow the Agency will review this copy, including
document publishes in the Federal instructions for submitting comments. the claimed confidential information, in
Register, but Web sites are subject to Comments submitted electronically, its consideration of comments. The
change over time. including attachments, to https:// second copy, which will have the
1. Investigational Device Exemptions www.regulations.gov will be posted to claimed confidential information
(IDEs) for Early Feasibility Medical the docket unchanged. Because your redacted/blacked out, will be available
Device Clinical Studies, Including comment will be made public, you are for public viewing and posted on
Certain First in Human (FIH) Studies; solely responsible for ensuring that your https://www.regulations.gov. Submit
Guidance for Industry and Food and comment does not include any both copies to the Dockets Management
Drug Administration Staff, available at confidential information that you or a Staff. If you do not wish your name and
https://www.fda.gov/downloads/ third party may not wish to be posted, contact information to be made publicly
medicaldevices/deviceregulation such as medical information, your or available, you can provide this
andguidance/guidancedocuments/ anyone else’s Social Security number, or information on the cover sheet and not
ucm279103. confidential business information, such in the body of your comments and you
as a manufacturing process. Please note must identify this information as
Dated: November 29, 2017.
that if you include your name, contact ‘‘confidential.’’ Any information marked
Leslie Kux,
information, or other information that as ‘‘confidential’’ will not be disclosed
Associate Commissioner for Policy. identifies you in the body of your except in accordance with 21 CFR 10.20
[FR Doc. 2017–26195 Filed 12–4–17; 8:45 am] comments, that information will be and other applicable disclosure law. For
BILLING CODE 4164–01–P posted on https://www.regulations.gov. more information about FDA’s posting
• If you want to submit a comment of comments to public dockets, see 80
with confidential information that you FR 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND do not wish to be made available to the the information at: https://www.gpo.gov/
HUMAN SERVICES public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
Food and Drug Administration written/paper submission and in the 23389.pdf.
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
[Docket No. FDA–2016–D–1210] Submissions’’ and ‘‘Instructions’’). read background documents or the
Written/Paper Submissions electronic and written/paper comments
Technical Considerations for Additive received, go to https://
Manufactured Medical Devices; Submit written/paper submissions as www.regulations.gov and insert the
Guidance for Industry and Food and follows: docket number, found in brackets in the
Drug Administration Staff; Availability • Mail/Hand delivery/Courier (for heading of this document, into the
AGENCY: Food and Drug Administration, written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and
sradovich on DSK3GMQ082PROD with NOTICES
HHS. and/or go to the Dockets Management
ACTION: Notice of availability. Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
SUMMARY: The Food and Drug • For written/paper comments You may submit comments on any
Administration (FDA or Agency) is submitted to the Dockets Management guidance at any time (see 21 CFR
announcing the availability of the Staff, FDA will post your comment, as 10.115(g)(5)).
guidance entitled ‘‘Technical well as any attachments, except for An electronic copy of the guidance
Considerations for Additive information submitted, marked and document is available for download
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![Federal Register / Vol. 82, No. 232 / Tuesday, December 5, 2017 / Notices 57463
from the Internet. See the process validation and verification Guidance documents are also available
SUPPLEMENTARY INFORMATION section for methods for these devices. To discuss at https://www.fda.gov/BiologicsBlood
information on electronic access to the these challenges and obtain initial Vaccines/GuidanceCompliance
guidance. Submit written requests for a stakeholder input, the FDA held a RegulatoryInformation/default.htm or
single hard copy of the guidance public workshop entitled ‘‘Additive https://www.regulations.gov. Persons
document entitled ‘‘Technical Manufacturing of Medical Devices: An unable to download an electronic copy
Considerations for Additive Interactive Discussion on the Technical of ‘‘Technical Considerations for
Manufactured Devices; Guidance for Considerations of 3D Printing,’’ on Additive Manufactured Medical
Industry and Food and Drug October 8–9, 2014 (79 FR 28732). Devices; Guidance for Industry and
Administration Staff’’ to the Office of This guidance is a leapfrog guidance; Food and Drug Administration Staff’’
the Center Director, Guidance and leapfrog guidances are intended to serve may send an email request to CDRH-
Policy Development, Center for Devices as a mechanism by which the Agency Guidance@fda.hhs.gov to receive an
and Radiological Health, Food and Drug can share initial thoughts regarding the electronic copy of the document. Please
Administration, 10903 New Hampshire content of premarket submissions for use the document number 1400002 to
Ave., Bldg. 66, Rm. 5431, Silver Spring, emerging technologies and new clinical identify the guidance you are
MD 20993–0002 or the Office of applications that are likely to be of requesting.
Communication, Outreach, and public health importance very early in
product development. This leapfrog IV. Paperwork Reduction Act of 1995
Development, Center for Biologics
Evaluation and Research, Food and guidance represents the Agency’s initial This guidance refers to previously
Drug Administration, 10903 New thinking, and our recommendations approved collections of information
Hampshire Ave., Bldg. 71, Rm. 3128, may change as more information found in FDA regulations. These
Silver Spring, MD 20993–0002. Send becomes available. The Agency strongly collections of information are subject to
one self-addressed adhesive label to encourages manufacturers to engage review by the Office of Management and
assist that office in processing your with CDRH and/or CBER through the Budget (OMB) under the Paperwork
request. Pre-Submission process to obtain more Reduction Act of 1995 (44 U.S.C. 3501–
FOR FURTHER INFORMATION CONTACT:
detailed feedback regarding their AM 3520). The collections of information in
Matthew Di Prima, Center for Devices device or process. For more information 21 CFR part 801 have been approved
and Radiological Health, Food and Drug on Pre-Submissions, please see under OMB control number 0910–0485;
Administration, 10903 New Hampshire ‘‘Requests for Feedback on Medical the collections of information in 21 CFR
Ave., Bldg. 62, Rm. 2214, Silver Spring, Device Submissions: The Pre- part 807, subpart E, have been approved
MD 20993–0002, 301–796–2507 or Submission Program and Meetings with under OMB control number 0910–0120;
Stephen Ripley, Center for Biologics Food and Drug Administration Staff’’ the collections of information in 21 CFR
Evaluation and Research, Food and (https://www.fda.gov/downloads/ part 812 have been approved under
Drug Administration, 10903 New MedicalDevices/DeviceRegulation OMB control number 0910–0078; the
Hampshire Ave., Bldg. 71, Rm. 7301, andGuidance/GuidanceDocuments/ collections of information in 21 CFR
Silver Spring, MD 20993, 240–402– UCM311176.pdf). part 814, subparts A through E have
The FDA considered comments been approved under OMB control
7911.
received on the draft guidance that number 0910–0231; the collections of
SUPPLEMENTARY INFORMATION: appeared in the Federal Register of May information in 21 CFR part 814, subpart
I. Background 10, 2016 (81 FR 28876). FDA has revised H have been approved under OMB
the guidance as appropriate in response control number 0910–0332; and the
FDA has developed this leapfrog to the comments. collections of information in 21 CFR
guidance to provide FDA’s initial
II. Significance of Guidance part 820 have been approved under
thoughts on technical considerations
OMB control number 0910–0073. The
specific to devices using additive This guidance is being issued collections of information in the
manufacturing (AM), the broad category consistent with FDA’s good guidance guidance document ‘‘Requests for
of manufacturing encompassing 3D practices regulation (21 CFR 10.115). Feedback on Medical Device
printing. In medical device applications, The guidance represents the current Submissions: The Pre-Submission
AM has the advantage of facilitating the thinking of FDA on ‘‘Technical Program and Meetings with Food and
creation of anatomically-matched Considerations for Additive Drug Administration Staff’’ have been
devices and surgical instrumentation by Manufactured Medical Devices.’’ It does approved under OMB control number
using a patient’s own medical imaging. not establish any rights for any person 0910–0756.
Another advantage is the ease in and is not binding on FDA or the public.
fabricating complex geometric Dated: November 30, 2017.
You can use an alternative approach if
structures, allowing the creation of it satisfies the requirements of the Leslie Kux,
engineered open lattice structures, applicable statutes and regulations. This Associate Commissioner for Policy.
tortuous internal channels, and internal guidance is not subject to Executive [FR Doc. 2017–26196 Filed 12–4–17; 8:45 am]
support structures that would not be Order 12866. BILLING CODE 4164–01–P
easily possible using traditional (non-
additive) manufacturing approaches. III. Electronic Access
However, the unique aspects of the AM Persons interested in obtaining a copy DEPARTMENT OF HEALTH AND
process, such as the layer-by-layer of the guidance may do so by HUMAN SERVICES
sradovich on DSK3GMQ082PROD with NOTICES
fabrication process, and the relative lack downloading an electronic copy from
of experience and clinical history of the internet. A search capability for all National Institutes of Health
with respect to devices manufactured Center for Devices and Radiological
Center for Scientific Review; Notice of
using AM techniques, pose challenges Health guidance documents is available
Closed Meetings
in determining optimal characterization at https://www.fda.gov/MedicalDevices/
and assessment methods for the final DeviceRegulationandGuidance/ Pursuant to section 10(d) of the
finished device, as well as optimal GuidanceDocuments/default.htm. Federal Advisory Committee Act, as
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Document Created: 2017-12-04 23:45:04
Document Modified: 2017-12-04 23:45:04
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on December 5, 2017. | |
| 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. | |
| FR Citation | 82 FR 57462 |
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