New Guidance on FDA ISO 10993-1
On 4 September 2020 FDA re-issued their guidance on the use of ISO 10993-1 and Biocompatibility. I don’t think anyone saw this coming. It’s a big surprise! But the good...
Multiple Function Devices
2020 has brought many challenges to industry and regulators alike. This is primarily due to the emergency response to the COVID-19 pandemic, but also in some instances due to other...
2019 US 510(k) Clearances Analysis and FDA’s target to receive innovative technologies first in 2020
We have recently been covering several new initiatives at the United States FDA CDRH, and as such thought it would be fitting to provide a round-up for the 510(k) activities...
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...
