Key figures highlighted by FDA regarding the 510(k) program:

In 2017, FDA cleared 3,173 devices via 510(k), comprising 82% of all new devices.
The average 510(k) submission in 2017 was 1,185 pages long – an increase of 150% compared to 2009.
FDA’s refuse-to-accept policy, which was first imposed in 2015 and updated in January 2018, checks incoming 510(k)s for 52 items. About 30% of submissions aren’t accepted on the first round.
Agency staff spend about 32% more time reviewing each submission than in 2009. Time spent reading each submission has about doubled in the last 15 years.
FDA has eliminated 1,477 devices as legal predicates due to safety concerns since 2012. This is 80% of the 1,758 devices eliminated as predicates since 1976.

Nudging Firms To Ditch Older Predicates: A Step In US FDA's Planned 510(k) Reforms

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