Regulatory Open Forum

 View Only

  • 1.  3D Printing

    Posted 14-Mar-2018 20:17

    Hello,

     

    Has anyone 3D printed a Class I or Class II instrument? I reviewed the FDA Guidance document, but still have several questions regarding testing, sterilization, and if this type of device would require a submission.

     

    Thank you!

     

     

     



Related Content