Australia Accepts US FDA 510(k) for Class III & IIa Devices

On 16 October, an amendment to Australian legislation was published that expands the conditions for medical devices already marketed in the US.

Can US FDA 510(k) Clearances Now Be Used for Australia Class IIa and III Devices?

For Class III medical devices, applications to include the products in the Australian Register of Therapeutic Goods (ARTG) can now be supported by US FDA 510(k) clearances. However, these applications must also include a Medical Device Single Audit Program (MDSAP) Quality Management System (QMS) certificate. Previously, the only form of US FDA evidence accepted for Class III devices was a Premarket Approval (PMA). It’s important to note that if an ARTG application for a Class III medical device relies on 510(k) clearance, it needs to undergo a mandatory audit by the TGA before being included in the ARTG.

Furthermore, ARTG applications for Class IIa medical devices, which are exempt from 510(k) requirements in the US, can now be supported solely by MDSAP QMS certification. Previously, all Class IIa device ARTG applications required 510(k) clearance as evidence of product assessment when relying on US FDA documentation.

You can read more about this update here.

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If you need guidance on meeting the Australia Class IIa and III regulatory requirements or have questions about including US FDA 510(k) clearances in your ARTG application, consult the TGA’s resource center or contact us for expert assistance.

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