I found another article that specifies the issues with the FDA’s center of medical device and radiological health. The main reason this article was released after the writer’s wife used the Karl Storz power morcellator which spread cancer throughout her abdomen. He focuses his article on life sustaining medical device flaws. He believes that the FDA focuses more on boosting the economy with innovations that do not take into account the safety of the public. The 510k is considered to a “dominant legal tool” which is used by CDRH. Noorchashm focuses on the fact that the 510k should be updated to consider the safety of Americans and users more than the innovation or capital the device could bring to the economy.

References:
https://www.mddionline.com/510k-under-attack
http://www.philly.com/philly/blogs/healthcare/A-Modern-Day-Wolf-in-Sheeps-Clothing-FDAs-Center-for-Devices-and-Radiological-Health-CDRH.html#qmBChtyv9S4YS5wb.99