MDMA Praises Reintroduction Of STRONGER Patents Act In Senate
The Medical Device Manufacturers Association (MDMA) on 10 July praised US Senate reintroduction of the STRONGER Patents Act, designed to strengthen the US patents systems by making it easier and less costly for patent-holders to enforce their patents, including those which are the intellectual property of device-makers. Mirror legislation was simultaneously proposed in the US House.
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In an exclusive interview with Medtech Insight, MDMA's Mark Leahey – one of industry's top lobbyists – talked about the group's priorities over the past year and its continued work on hot-button issues, including medical device-tax repeal, reimbursement and implementing MDUFA IV provisions. He also discussed the imminent departure of US FDA Commissioner Scott Gottlieb and the recent federal government shutdown.
FDA’s Device Center Could Raid $2.8M From Staff Outreach, Training Kitty In 2021 To Fund Other CDRH Needs
While the Trump administration’s proposed fiscal year 2021 budget for the US FDA would give the agency’s device center a 5.3% increase for medtech product approvals and safety, the center’s lofty plans to become the world’s premier regulator of new AI-driven gadgets, next-gen diagnostics and other novel devices means it will have to tap about $2.8m dollars usually set aside for staff training and outreach to help meet its ambitious goals.
Novacyt, Co-Diagnostics, Other Test Firms Seek Fast-Track EUA Approval From FDA For Coronavirus Dx's
Diagnostics companies around the world – including Novacyt, Roche, Co-Diagnostics and Mammoth Biosciences – are developing and launching tests to fight the coronavirus in China and other countries as quickly as possible, and some are seeking Emergency Use Authorization (EUA) approval from the FDA so their assays can be used on US patients.