Australian regulators have started accepting decisions made by the U.S. FDA as evidence to support medical device authorization submissions.
The change means device manufacturers that have already been through the U.S. regulatory process can benefit from an abridged conformity assessment in Australia.
Australia’s device processes remain more closely aligned to Europe, though, limiting the ways in which paperwork from the FDA can be used.
The Therapeutic Goods Administration (TGA) of Australia began waiving application audits for devices cleared by notified bodies in the European Union years ago. The mechanism allows companies to use conformity assessments performed in Europe to access the Australian market, thereby reducing the regulatory burden and encouraging more manufacturers to sell devices in the country. However, the abridged pathway was closed off to companies with devices authorized in the U.S. but not Europe.
Following a review of regulatory practices in the country, the Australian government told the TGA to change its policy. The result is companies can now leverage paperwork from the FDA to bring their devices to market in Australia, although documentation from Europe still opens more doors.
Under the new system, companies that submit details of premarket approvals (PMAs) from the FDA benefit from the abridgment of the "examination of the design" part of the conformity assessment. The TGA also wants developers of Class IIb medical devices to include their PMAs, de novo decision summaries or 510(k) summaries in applications to bring products to market in Australia.
This information only clears some regulatory barriers, though. Companies that have brought Class IIb implantable devices to market in the U.S. via the 510(k) and de novo pathways can include information related to these authorizations in their Australian filings. However, TGA will continue to check if the authorizations are aligned with its regulatory requirements and is likely to subject them to application audits. As such, applicants will need supporting documents and clinical evidence.
The TGA has also begun accepting evidence from regulators in Canada and Japan, as well as reports issued through the International Medical Device Regulators Forum’s Medical Device Single Audit Program.