Guidelines on 3D printing

[ChiJug49]

Hi All! I want to start a 3D printing lab and I was wondering if there are any general guidelines that lab owners/managers are looking at (besides manufacturer IFU) to implement with their in-house 3D printing workflows. Things to consider include hazmat waste collection protocols (by who and what regulation?),IFU and sterilization protocols (mainly for printed surgical guides),or maybe a DAMAS-type quality system?

I don't believe that there are any audits or inspections being done by letter agencies or manufacturers (at this point) but I don't think that it will be like this forever. I wonder how or what this could look like for labs or what/how we want this oversight to look like? Does FDA, state agencies or manufacturer perform audits or inspections to ensure that IFUs are being followed?

Thanks for your help!!

 

[Foggy_in_RI]

You first have to decide what type of work you want to do- this will determine what regulations you are subject to with respect to the FDA.

Surgical guides were mentioned- so you will have to register your dental lab.

How to stay on top of FDA Dental Regulations

All dental labs must have a Quality System in place, however, all components of FDA Dental Regulations don’t apply to all business models...

info.safelinkconsulting.com

All dental laboratories do not have to register with FDA. However, there are a number of factors that would trigger registration with FDA. Some of them are:

• The manufacture of Class II Medical Devices such as Apnea Devices, Snoring Devices, TMJ splints, and in-house milling of customized implant abutments
• Repackaging or Relabeling of a medical device
• Importing finished appliances from an Offshore Dental Laboratory
• Foreign Dental Laboratories

 

[GG - J]

MSN

Bryson DeChambeau uses 3d printed clubs​