FDA

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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...
Clearing fog

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....
Door closed

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...
End of financial year

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...
Red carpet

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...
Implant

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...
hip joints

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...
Lightbulb

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...
Team work

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...
HarmonisationXarticleXimage

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...

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