FDA’s Device Program Really is in Crisis
In July, a subcommittee of FDA’s Science Board released a cleared-eyed 37-page report on what it called the “financial and strategic threats” confronting CDRH’s regulatory science and engineering programs.
Composed of seven academic and industry outsiders, the subcommittee could say things no FDA employee would be allowed by political considerations to say.
Foremost among these was the warning that politically imposed loss of federal investment in CDRH regulatory science “will interfere with the regulatory approval of emerging technologies and in doing ...
