Changes to US 510(k) filing requirements under discussion
This article was originally published in Clinica
The US FDA had high expectations in 1998 when it unveiled two alternative paths to market that it called the "new 510(k) paradigm". Both paths eliminated the need for companies too file underlying data for their products, which the FDA expected would streamline the application process.
You may also be interested in...
HAL Allergy Group, developer of products for allergy diagnostics and allergen immunotherapy, promoted its principal scientist to chief R&D officer; Starkey Hearing Technologies brought on new health and business development execs to expand its global footprint; and more.
As the coronavirus continues to spread, one of the big four global vaccines companies has committed itself to the fight.