查看文章

Amidst sweeping changes to the United States health care system ushered in by the Patient Protection and Affordable Care Act (" ACA"), the Food and Drug Administration (" FDA") continues to struggle to apply often centuriesold product categorizations to emerging technological innovations. The ACA's introduction of a" biosimilar" pathway to market for biological products, modeled on abbreviated pathways to market for drugs and medical devices, further complicates the assessment of" safety" and measures of equivalence and similarity that allow products to enter the market faster. One area where this is particularly acute is nanobiotechnology, which has enabled a set of products that drift uncomfortably at the interface of drugs, medical devices, and biologics, blending unique and novel biological properties at the nanoscale that integrate chemical, mechanical, and biological aspects into a wide range of consumer …