FDA Gives Insight On Changing Approval Landscape
Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.
You may also be interested in...
The guidances outline testing and performance criteria for Foley catheters and cutaneous electrodes submissions through the new abbreviated 510(k) pathway.
A new proposed rule on the de novo classification process does not advance any major policy reforms, but its release underscores the growing popularity of the regulatory pathway that provides flexibility for US FDA and industry in the space between 510(k)s and PMAs.
The agency says 510(k)s submitted via an electronic template for any of about 40 product types might get a speedier review under a new pilot program.