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...
Harmonization in Plain Sight. Are FDA and CE Substantially Equivalent?
Medical device harmonization continues to struggle, with substantial differences between FDA and Europe continuing to be an obstacle. However, current changes in Europe and proposed changes in the US may...
Not so fast. What really happened with FDA’s clearance of the Apple Watch ECG
There’s lots of noise about the very rapid de novo clearances for Apple’s “Irregular Rhythm Notification Feature” (DEN 180042) and ECG App (DEN180044) for the Apple Watch. FDA cleared both...
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...
Risk vs. Benefit FDA guidance gets to grips with uncertainty
Doing risk management in an uncertain world is why regulatory affairs are as much art as science. Innovators will continue to push the envelope of the possible while regulators will...
