... manufacturer implemented coring testing as part of their quality control. To prevent coring needles from entering the market as a result of manufacturing flaws, optical inspection of the heel edge and coring testing should be performed as part of routine quality control. Offset from the needle shaft...

... required use of this device. Yet, because HUDs are limited to 4000 cases per year, the product could not be sold to the larger patient group. The FDA prohibits such use due to insufficient quality controls and a lack of proper documentation; the agency does not want to encourage companies to use HDE...