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...
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...
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...
FDA raises fees 4%
The new US financial year as always heralds increases in regulatory fees. FDA published its 2019 fees at end of July. Fees are up around 4% across the board. The...
