Arthur Brandwood

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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...
FDA

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...
Uncertainty

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...
Sauce

China update – regulation with a European sauce?

CFDA continues to propose more changes to medical device regulation, and as ever the agency looks to international practices and seeks to weave them in to China requirements. A recent...
Ventilator patient

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...
TGA introduces new Class Device application Fee, plus general 1.9 percent increase. Brandwood Biomedical Global Medical Device and IVD Regulatory Services

TGA introduces new Class I Device application Fee, plus general 1.9% increase.

In a long-anticipated change, TGA today announced the introduction of a new $530 application fee for Class I medical devices and an overall increase of 1.9% to most other TGA...

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