Australia's Therapeutic Goods Administration proposed a regulatory change regarding personalized and 3-D printed medical devices and implants, according to the 3D Printing Industry.
Here are five things to know:
1. After concerns current regulatory guidelines are not satisfying goals to "mitigate risks to patients, and to meet requirements for healthcare providers and manufactures," the TGA hopes to redefine personalized devices and clarify requirements for high and low risk medical devices.
2. Currently, 3-D printed implants are considered low risk custom devices because of a loophole in existing regulation. New regulations would classify these implants as high risk devices.
3. Along with redefining personalized devices, the TGA redefining what constitutes as a manufacturer. The new definition would require anyone who modifies a device already on the market to be liable for the same responsibility as the original equipment manufacturer.
4. The new regulations do not affect mass produced 3-D devices, such as Stryker's posterior lumbar cages or SI-Bone hip implants, because the devices are not personalized on a per-patient basis.
5. Additionally, there are proposals for new guidelines for devices with "human material," such as bioprinted scaffolds, and new classification for anatomical models and digital 3-D printed files.