TGA acceptance of international device reviews – clearing the fog
A recent discussion on the RAPS bulletin board (link here for members) revealed confusion as to what international evidence can be used to support Australian regulatory approvals for medical devices....
The door to Europe is closed – so where else should I look?
Early in 2019, the European commission was promising that by end of year MDR implementation would be well underway. There would be substantial numbers of Notified Bodies designated to perform...
Out They Go – FDA Clears the Store of Guidances
In a now traditional clearing of the store, FDA issued a raft of new guidances at the close of the financial year. Through September to October 10 a total of...
FDA Fashion Parade – Guidance Priorities for Fiscal 2020
Each new fiscal year, FDA sets out its priorities for guidance development and publication over the coming year. It’s always a fascinating insight into the current regulatory fashions, and just...
Custom Devices, Clinical Trials and the Hazards of Precedent
This past week an interesting post cropped up in the RAPS discussion board. An Australian member asked about doing clinical trials of custom-made medical devices. A surgeon inventor wanted to...
Test or Evaluate? Biocompatibility and Orthopaedic materials
This morning, the US FDA announced with a tweet, the publication of a new guidance on Ultra High Molecular Weight Polyethylene (UHMWPE) in Orthopaedic devices. "Manufacturers should include test data...
510k Modernization in progress
In our live webinar of January 2019 “Making American Guidance Understandable Again”, we highlighted a range of FDA initiatives towards a modernization of the US Medical Device Regulations. During that...
All Together Now – FDA Builds Devices Super Office
The biggest difference between the FDA way and the rest of the world is the separation of activities into device assessment, which comes first and involves FDA reviewers from the...
