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...
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...
