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Latest From Ferdous Al-Faruque
Overhaul of reg on how combo products are designated to review centers eliminates the reconsideration appeal, but US FDA still allows appeals up the chain of command.
In an overhaul of a regulation that sets out how US FDA designates combo products to product centers, the agency is proposing to update its policies so they align with current practices and mandates. FDA is also specifically proposing to streamline a designation appeal process that it says has been a burden for all parties.
In prepared remarks shared with Medtech Insight, AdvaMed plans to argue that tariffs imposed on medtech products made in China would disrupt an ongoing "action plan" the industry is pursuing to achieve reciprocal market access between the US and China for the industry.
In a podcast exclusive with Medtech Insight, the new chair and executive director of small-company-focused AdvaMed Accel discussed their priorities for supporting small medtech companies. Among the topics discussed were the medical device tax, reimbursement uncertainty and empowering women in the industry.
Device tax, reimbursement predictability and empowering women in the medtech industry are some of Martha Shadan's top priorities for her two-year term as board chair of AdvaMed Accel, the small-company-advocacy arm of the trade group.
In a Medtech Insight exclusive podcast interview, US FDA's Bakul Patel talks about what the agency wants to learn from a newly released "working model" intended to set the initial foundations for the digital health pre-certification program. The first version of the program will start before year's end and he's hoping for industry feedback to prepare for it.