Guidelines on 3D printing

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ChiJug49

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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!!
 
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Foggy_in_RI

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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.


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 Sleep 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
 

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