Two core principles of American criminal liability are: (1) a crime does not occur unless the accused has both criminal intent (mens rea) and commits a criminal act (actus reus); and (2) the intent and the act must occur at...more
4/9/2019
/ Corporate Officers ,
Criminal Liability ,
Criminal Prosecution ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Safety ,
Legislative Agendas ,
Negligence ,
Park Doctrine ,
Proposed Legislation ,
White Collar Crimes
FDA's "510(k)" process, by which a medical device manufacturer can bring a product to market based on the premise that the proposed device is the substantially equivalent to a an already legally marketed "predicate device",...more
On April 27, the Food and Drug Administration (FDA) released its promised draft guidance document, Multiple Function Device Products: Policy and Considerations, explaining how it will regulate multiple function devices that...more