FDA’s Perspective on 3D Printing of 

Medical Devices

Materials Scientist 

Chair of FDA’s Additive Manufacturing Working Group

Center for Devices and Radiological Health (CDRH)

Office of Science and Engineering Laboratories (OSEL)

Division of Applied Mechanics

Roadmapping Workshop: Measurement Science for Polymer-Based AM

June 9-10, 2016 

Matthew Di Prima, Ph.D.
Disclaimer

The mention of commercial products, their 

sources, or their use in connection with materials 

reported herein is not to be construed as either an 

actual or implied endorsement of such products by 

the Department of Health and Human Services. 
Overview of CDRH’s AM Experience 

• Regulated devices have 

been additively 

manufactured for more than 

a decade 

• AM devices have been 

regulated through the same 

pathways as non-AM 

printed devices

• 70+ AM Devices cleared 

through the 510(k) pathway

• Majority of 510(k) 

clearances for orthopedic 

applications

• There have been some 

“emergency use” of AM 

devices

• First 3D printed drug 

approved in August 

(Spritam) via CDER
Overview of AM materials and technologies

4

Laura Ricles et al, 2015
• Patient matched implants

– Skull plate

– Maxillofacial 

implants

• Patient matched surgical 

guides

– Craniofacial

– Knee

– Ankle

• Orthopedic devices

– Hip Cups

– Spinal Cages

– Knee trays

• Dental

– Temporary bridges

– Reconstructive surgery 

support

K121818

OsteoFab by OPM

http://www.accessdata.fda.gov/c

drh_docs/pdf12/K121818.pdf

K102776

e-DENT Temporary Resin

by DeltaMed GmbH

http://www.accessdata.fda.gov/c

drh_docs/pdf10/K102776.pdf

K102975

Novation Crown by Exatech

http://www.accessdata.fda.gov/cdrh_docs

/pdf10/K102975.pdf

K120956

VSP® by Medical 

Modeling

http://www.accessdata.fda.gov/cd

rh_docs/pdf12/K120956.pdf

Types of 510(k) Cleared AM Devices
Other polymer based medical applications

Unpowered prosthetics Patient models

http://enablingthefuture.org/upper-limbprosthetics/

http://www.3der

s.org/articles/20

150604-

lightweightkafo-splint-3dprinted-legbrace-costeffectivelycustomized-forperfect-fit.html

http://www.fda.gov/downloads/MedicalDe

vices/NewsEvents/WorkshopsConferenc

es/UCM418406.pdf
TECHNICAL CONSIDERATIONS 

FOR ADDITIVE MANUFACTURED 

DEVICES
Draft Guidance

• Presents FDA’s initial 

thoughts for comment by 

the public

• 90 day comment period, 

closes August 8

• When finalized, guidance 

represents agency’s 

current thinking

• Draft guidance addresses 

both Manufacturing and 

Design Considerations as 

well as Device Testing 

Considerations

https://www.regulations.gov/#!documentDetail;D=FDA-2016-D-1210-0001 or 

search FDA docket draft guidance additive manufacturing
Manufacturing and Design

• Device Design

– Separate concerns for 

standard and patient 

matched designs

• Software Workflow

– Concerns ensuring 

proper file conversion 

and software 

interactions

– Slicing, support, and 

build pathing could all 

affect final device 

performance
Manufacturing and Design

• Materials Control

– Starting material 

should be fully 

characterized 

(including processing 

aids)

– Material recycling 

protocol should be 

validated

• Post-processing

– Post processing can 

have a significant 

impact on device 

performance
Manufacturing and Design

• Process Validation 

and Acceptance

– Validation is a key 

component when full 

verification testing can 

not be performed

– Revalidation can be 

needed when there is 

a change in the 

process

• Quality Data

– Validation activities 

and design 

specifications will 

determine what data 

needs to be retained
Device Testing

• Device Description

– Type of AM 

technology used and 

manufacturing 

workflow/post 

processing expected 

• Mechanical Testing

– Worst case 

consideration should 

include orientation and 

build location

• Material 

Characterization

– Looking to 

characterize the 

material in the final 

device 

– Understand if there 

are any adverse 

material effects from 

the AM process
Manufacturing and Design

• Cleaning and 

Sterilization

– Complex structures 

and channels could 

lead to challenges in 

cleaning (both 

manufacturing and 

reprocessing)

• Biocompatibility

– Follow existing 

standards

• Additional Labeling 

Considerations 

(Patient Matched)

– Revision of design

– Anatomical descriptor

– Patient identifier
Thank you!

Matthew Di Prima, FDA

Matthew.diprima@fda.hhs.gov