TGA Weighs Changes to Regulations for Personalized, 3D Printed Devices
By Michael Mezher -
Published 09 November 2017
Australia's Therapeutic Goods Administration (TGA) on Thursday launched a consultation on proposed changes to the country's medical device regulations for personalized and 3D printed medical devices.
Categories: News, Oceania, TGA, Manufacturing, Medical Devices, Submission and registration
Tags: 3D-Printing, Custom Medical Devices
Custom Devices: Improving Patient Quality of Life and Clinician Capabilities
By Carol Vierling -
Published 19 November 2015
This article discusses the definition of a custom device, how a custom device is developed and regulations to be followed to place a custom device on the market. The article also discusses when a compassionate use request may be appropriate.
Categories: Features, US, CDRH, Compliance, Medical Devices
Tags: Custom Medical Devices, Custom Device Exemption, FDASIA, Patient-Specific Devices, Compassionate Use
Custom Medical Device Definition Clarified in Final FDA Guidance
By Alexander Gaffney, RAC -
Published 24 September 2014
The US Food and Drug Administration (FDA) has issued a new final guidance document intended to clarify the process by which manufacturers of "custom" medical devices can comply with federal regulations.
Categories: News, US, CDRH, Medical Devices, Submission and registration
Tags: Custom Medical Devices, Custom Device Exemption, Custom Device, Guidance, Final Guidance