FDA

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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...
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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...
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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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FDA and ISO stars aligning on ISO 10993

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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...
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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...
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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...
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FDA gives thumbs up to digital submissions

In a proposed rule announced 13 September, US FDA plans to do away with paper submissions. The agency isn’t quite going fully digital yet – you still have to mail...
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Australia via 510(k): TGA – recognises US, Canadian and Japanese approvals with MDSAP

Australia’s regulatory system is modelled very closely on that of Europe. This equivalence of requirements and assessment pathways has allowed TGA to leverage prior CE marking to grant Australian device...
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Biocompatibility of Breathing Gas Pathways

ISO 10993-1 requires that devices which contact the body indirectly - by means of a fluid or gas passed through the device and into the patient - must be assessed...

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