US Food and Drug Administration (FDA) releases guidance on use of 3D printing for medical applications

[Dr. Mike]

The US Food and Drug Administration (FDA) just released guidance on the use of 3D printing for medical purposes in the USA. 

 

http://threedmedprint.springeropen.com/articles/10.1186/s41205-016-0005-9

 

I am particularly interested in how the FDA approval applies to software used to generate models that are used for surgical planning but not diagnostic purposes? It seems, from the article, that if the purpose of the 3D printed model is merely for thinking about or planning a surgery, it is a "visual aid" and FDA approved software is not required. The technical term is a "medical image hardcopy device," examples of which are laser printers and cameras. If it is used for diagnosis, then it should be discussed with the FDA. And if use for implantable medical devices or surgical cutting guides (i.e. stuff that touches the patient), then the whole process is under FDA approval. This correlates to what the paper's first author (Matthew Di Prima from FDA) said at the 2015 Bioinformatics Festival during this talk. Key part is at 4:41.

 

https://videocast.nih.gov/summary.asp?Live=15417&bhcp=1

 

Anyone have any thoughts about this?

[Dr. Mike]

Given the degree of uncertainty regarding this topic, I decided to go to the authoritative source, and contacted Matthew Di Prima, author of the article in question here and head of the Additive Manufacturing Working Group at the FDA. The focus of the FDA regarding 3D printing at this time is on surgical implants and cutting guides -- devices that actually touch the patient. Regarding 3D printed models for the surgeon to touch and hold and think about -- surgical planning models -- the stance of the FDA is that at this time they are "not concerned about patient specific models." This is government-speak for saying that currently it is unregulated, but the FDA wants to reserve its right to regulate it in the future and doesn't want to  commit to a position at this point. 

 

So there you have it. FDA cleared software is not required for production of 3D printed patient-specific models for surgical planning at this time, but the FDA reserves its right to change that stance in the future.