A single review program for medical devices?
During this year’s Bio-Utah Summit in November 2019, Dr. Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health (CDRH) spoke about the new initiatives and modernization of...
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...
Are Harmonised Standards facing irrelevance?
There’s been considerable disquiet over the lack of availability of harmonised standards to support the new European Medical Device Regulations (MDR). And rightly so. But harmonisation is already in disarray...
The question on clients’ lips… “How long will my application take?”
Every year the TGA produce the TGA Annual Performance Statistics Report and the Half Yearly Performance Snapshot. On the 21 October 2019, The TGA released the latest annual statistics on...
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...
