Op-Ed: What Do “The Hunger Games” and 510(k) Have in Common? More Than You’d Think.
MDDI Device Talk Blog
Posted: April 29, 2013
Like the tributes thrust into the Hunger Games arena, medical device manufacturers want a fair shot at surviving the everchanging FDA 510(k) pathway.
The FDA 510(k) program is beautiful and practical in its simplicity, and yet sophisticated in its ability to accommodate complexity and flexibility. It is as maligned as it is revered. But describing the nuanced process in detail is far too complex, as it requires an admixture of macro and micro politics, political philosophy being subtly carried out, and regulatory and administrative law, medicine, and science.
By putting it into a caricature using the pop culture phenomenon The Hunger Games, however, I have tried to provide an amusing analogy to demonstrate what it’s like to take a client through the surprise-filled arena we call the 510(k) program as well as some tips on how to make it out alive.