Pathways’ Picks September 7: Fee Watch, Software Guides, and More

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ARTICLE SUMMARY:

In this week’s round up: Steep industry fee hikes proposed by UK’s regulator, while FDA and industry hope for quick action on US user fee reauthorization, and China institutes electronic fee payments. Also, work on software guidance documents in the UK and US, another Philips Respironics recall, a Eurasian regulatory extension, and dates to remember.

Fee Watch

Eye on regulatory fee issues in the UK, US, and China:  

UK proposes steep fee hikes. Device regulatory notification and registration fees in UK would double or even triple next year under a proposal from the UK Medicines and Healthcare products Regulatory Agency. MHRA also proposed to add 22 new drug and device fee categories, including fees for device clinical investigation consultations with the agency and linked to the submission of IVD performance reports. MHRA published its proposal last week to recover cost shortfalls, noting that it hasn’t updated drug fees since 2016/2017 and device fees since 2017/2018. The proposal, which would take effect in April 2023, also comes as MHRA is preparing to transition to a new regulatory structure for devices and IVDs distinct from the EU framework. “In recent years there has been substantial technological progress in the field of medical devices and increased rigor is required in order to accommodate the growing complexity of modern devices,” the agency states. “This requires the MHRA to extend scrutiny of these devices, which is more resource intensive and time consuming.” 

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