FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Australia Issues Draft Guidance on Personalized Devices

March 5, 2019
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Australia’s Therapeutic Goods Administration is seeking feedback from devicemakers on how personalized devices should be regulated.

The guidance defines personalized medical devices as those devices that are manufactured for a particular patient, including 3D-printed devices. These devices are currently covered under the custom-made medical device definition.

In a November 2017 consultation paper, the TGA noted the increasing use of 3D printing for medical applications was raising concerns about the adequacy of the current regulatory framework to mitigate risks to patients and to meet requirements for health care providers and manufacturers.

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