There is a troubling loophole in the US Food and Drug Administration’s 510(k) pathway that allows for the approval of medical devices that are at a higher risk of recall, according to results of two ...

Contemporary orthodoxy affirms that singular terms cannot be predicates and that, therefore, 'is' is ambiguous as between predication and identity. Recent attempts to treat names as predicates do not ...

Food and Drug Administration’s modernization plan for its 510(k) process may not be all sweet music to the industry. In a joint statement on Monday describing the modernization effort, Commissioner ...