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Latest From David Filmore
510(k) clearances are the US market on-ramp for most devices, and proving the device is similar enough to an already-marketed product is the entry toll. But a policy in development at FDA's device center offers an optional approach that avoids predicate comparisons. Center director Jeffrey Shuren says in an interview that he expects the new approach will become the "pathway of choice" for many companies, potentially upending what has been a defining characteristic of the device regulatory landscape for decades.
AdvaMed told Republican leaders of the House and Senate that they should rethink any plans to wait until next year to pass a retroactive suspension of the device tax, after the tax has already been reinstituted. The tax needs to be addressed by Dec. 31 to avoid a costly, bureaucratic nightmare, the industry group argues.
On this week's podcast, we discuss our latest MTI 100 rankings, providing a view on top revenue-getters in the medtech space, and we look at issues that are driving up and down movements on the list.
The US agency issued a draft guidance that brings the 20-year old concept of "least burdensome" in medical device regulation to all corners of the device center's activities.
Four novel molecular diagnostics, including two next-generation sequencing platforms, gained FDA approval in November, almost half of the nine novel-device approvals last month. The agency was also active with PMA supplement approvals and 510(k) clearances during the period.
The commissioner explained to senators he is trying to go beyond the 21st Century Cures Act to further encourage development of innovative digital devices.