The main theme running through FDA's guidance on ISO 10993-1 is that every medical device should be assessed for its specific risk to the end user.
Audrey Turley and Thor Rollins
In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, which addressed "adulterated" products. Adulterated includes the addition of fillers of reduced "quality or strength;" coloring to conceal "damage or inferiority;" formulation with additives "injurious to health;" or the use of "filthy, decomposed, or putrid" substances in a product. It took until 1995 for FDA to release an official guidance specific to medical device regulation.
This document, known as the “blue book,” was the basis of biocompatibility regulation for decades. FDA published a draft...