Shawn M. Schmitt
Latest From Shawn M. Schmitt
Medtech Monthly is here! Check out the first episode of Medtech Insight's new podcast series: It's a knock-down (not really), drag-out (not really), freewheelin' (very much so) conversation about quality versus compliance, with the US FDA's Cisco Vicenty in one corner, and former FDA compliance chief Steve Silverman in the other.
The US FDA compliance officer says medtech manufacturers would be wise to evaluate changes to stay out of hot water with the agency.
The US FDA is teaming up with the Medical Device Innovation Consortium to establish the clearinghouse, which would nudge medtech companies to adopt novel approaches that could take their manufacturing operations to a higher level.
In this revealing interview, the new acting director of the US FDA’s Digital Health Center of Excellence talks about his new role at the DHCOE, the big shoes he’ll have to fill now that former center head Bakul Patel is gone, the need for new regulatory frameworks for digital health – and how he helped repair the Hubble Space Telescope.
The US FDA may launch a pilot program that would allow PMA-holders to submit updated master files to the agency if the manufacturers change sterilization methods.
Baxter Healthcare says there’s a risk of decreased oxygen levels or lung over-expansion when using its Volara System “in line with a ventilator.” The firm launched a recall of the device on 1 June.