FDA Hits User-Fee-Era Record For 'Novel' Devices: A New Normal?
This article was originally published in The Gray Sheet
Approvals of PMAs and panel-track supplements, as well as de novo devices, hit a 15-year high in calendar year 2015, according to a "Gray Sheet" analysis. FDA and industry experts respond to the data; also, check out our infographic of 2015 FDA approval trends, including a tally of the firms that captured the most PMAs and 510(k)s last year, and more.
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2017 was another record year for novel device approvals in the US, with typical large numbers of cardiovascular and IVD go-aheads, along with notable successes in neurology, with noninvasive stimulation and digital-app solutions seeing success. There was also an increase in 510(k) clearances last year. Here's a look at some key FDA approvals and clearance trends from the past year, including in infographic form.
The privately held Indiana-based device firm has accelerated its 510(k)-clearance output this year, leading all firms with 19 in the third quarter, and pulling neck-and-neck with perennial leader Medtronic for 2017. Overall, FDA remains relatively steady on 510(k) volumes and is maintaining its accelerated pace of novel-device approvals.
The 18% of FY 2015 PMA and HDE device approvals that included pediatric indications was the lowest proportion since FY 2009, even while, overall, 2015 was a record-setting year for novel device approvals.