Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear Community-

Our company is in the early stages of evaluating 3d printing and we will begin the process of vetting 3d vendors, and want to ensure we are evaluating possible partners correctly because the guidelines for 3d printers are still evolving and we do not have any experience in-house.    Below are a few questions that we have at the moment.

What kind of information would be necessary/helpful to support applications with 3d printing? Is there a standard package of information we should request from our vendor or does the extent of information vary a lot?

We've heard some feedback that introducing new material or software versions may cause some issues. Do you have insight on why this would be a concern? 

What sort of road blocks do we need to be on the lookout for or pitfalls you commonly see?

Does anyone provide consulting or recommend a resource to contact regarding 3d printing?

Any guidance that can be provided is greatly appreciated.

Thank you for your time and assistance.

Dear Anonymous,

I found a little difficult to look for information for your question because you did not specify its area of use and the role of 3d printing in your device's use- is the device itself 3d printed or will a 3d printed accessory enable application of your device? Are you interested in US regulations?

Assuming you have already read about FDA's thoughts on 3D printed devices at:
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/3DPrintingofMedicalDevices/default.htm

it will be useful to read these 2 guidances:
Technical Considerations for Additive Manufactured Medical Devices
Custom Device Exemption

The first guidance elaborates on material use, characterization and software workflow which are some of your concerns. I think it may be useful to look up products of companies that have registered and marketed 3d printed prostheses as a starting point.
http://industrial.xilloc.com/
http://www.anatomics.com/applications/

Hope this helps.

------------------------------
Vidyalakshmi Jayaraman
RA Specialist
MA
United States
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Original Message:
Sent: 19-Dec-2017 08:40
From: Anonymous Member
Subject: 3d Printers

This message was posted by a user wishing to remain anonymous

Dear Community-

Our company is in the early stages of evaluating 3d printing and we will begin the process of vetting 3d vendors, and want to ensure we are evaluating possible partners correctly because the guidelines for 3d printers are still evolving and we do not have any experience in-house.    Below are a few questions that we have at the moment.

What kind of information would be necessary/helpful to support applications with 3d printing? Is there a standard package of information we should request from our vendor or does the extent of information vary a lot?

We've heard some feedback that introducing new material or software versions may cause some issues. Do you have insight on why this would be a concern?

What sort of road blocks do we need to be on the lookout for or pitfalls you commonly see?

Does anyone provide consulting or recommend a resource to contact regarding 3d printing?

Any guidance that can be provided is greatly appreciated.

Thank you for your time and assistance.