FDA Legality Question
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Hello,

 

I'm hoping to find some answers to questions regarding the legalities of selling 3D rendering/printing services for local clinics.

 

I have worked in Radiology as an X-Ray tech for 13 years as well as for my local Diagnostic Imaging Program as an adjunct instructor for 7 years. I am currently assessing the market for 3D modeling/printing services to clinics and hospitals. I have read the information from the FDA including the slides you have posted. If you don't mind I was hoping to ask you if you know of any clarification regarding the following:

 

If a 3rd party company were selling 3D rendering/printing services of patient specific anatomy using imaging studies (CT,MRI) stated that the models were "not for diagnostic use" would that still require said 3rd party company to use FDA approved software to do so? If the models were used for diagnostic use would that fall under the liability of the MD or the 3rd party company or both?

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FDA approved software (MIMICS and 3-Matic from Materialise) must be used only for implants design (as said in 3D SIG and FDA meeting last year). Regarding making patient specific models for surgery planning etc. you can use other software (open source). @Dr. Mike correct me if I am wrong, since you are from the States :)

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That's what I am a little confused about. The FDA refers to the software itself as a type II medical device. It seems that one must use an FDA approved software if *services are going to be rendered to a Doctor or facility.

 

It seems that Doctors themselves can use any software they want to create these prints. 

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You are correct about the doctors. That is the current understanding based on information given at the RSNA SIG meeting in August 2017. The FDA does not regulate the "practice of medicine" and doctors can, at their discretion, use whatever software they wish. The situation is different for a hospital or company that is offering a for-profit 3D printing service and advertising for diagnostic use. They need to use FDA approved software that is approved for that use. The reason I include that emphasis is that most FDA approved software is actually not approved for 3D printing, and it's use is thus off-label. Yet, the companies that sell it conveniently forget to tell people about this. Materialise just announced on March 23, 2018 that their inPrint software is FDA approved for 3D printing for diagnostic use, and is supposedly the first software with such approval. They are making a big deal about it, but for years they have been marketing their Mimics software for 3D printing as "FDA-approved." I guess they left out the part that it isn't specifically approved for 3D printing.

 

The first slide below is from a talk I gave at the Mayo Clinic Collaborative 3D Printing in Medical Practice conference in Scottsdale in February 2018. It is a direct quote from an FDA talk about when FDA-approved software is required. The second slide is a matrix of who needs to use FDA-approved software and who doesn't and for what type of use. The data is extracted from the FDA slide deck, which I encourage you to read directly at the link below. This could change, but is their current opinion. 

 

https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM575723.pdf

 

It seems that if you are going to market a 3D printing service you need to either use FDA-approved software that is approved for that use, of which there is only one (inPrint), or make clear to your clients that the models are not for diagnostic use. Of note, Materialise has been selling models for years and shipping them with paperwork that says they are not for diagnostic use, so there is precedent.

 

Please note that this is my opinion, and things could change, and this shouldn't be construed as medical or legal advice, etc, etc. Good luck!

 

 

FDA slide.JPG

 

matrix.JPG

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Thank you so much Dr. Mike, and thank you for creating this community. I learned about it through an ACERT conference for radiology and have been on here ever since.

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