Reading for 10/3

Three Interesting Things:

1.) I think it is interesting that both drugs and medical devices are documented in the US Pharmacopoeia. I assumed that they would be classified in different areas because of their difference as well as the vast amounts of both that there are.
2.)I find it interesting that the FDA is trying to modernize the clearing process into the market since they allow class I to II or moderate to low risk devices to not have to be approved but rather cleared instead. I would think that you would want to clear and approve everything just to be safe. Even though devices can be low risk that does not mean the a problem can occur that could cause a bigger issues for manufacturers. From what I have read in the last two weeks it seems as the the FDA and other regulatory committees have "beat around the bush" in some ways to expedite the process to market.
3.) I think it is interesting that there are much connections between approval processes of drugs verses medical devices. A drug manufacturer has to file an NDA for approval while a medical device manufacturer has to file a PMA. They both have to go through much to come to market but I feel as though it is easier for a medical device to get to market rather then a drug even though they both have ultimately the same intended purpose.

Three Questions:

1.) Why are some classes of medical devices exempt from the 510 K versus others? Is it due to the risk of the different classes?
2.) Is Trump's plan to make a new FDA commissioner for the greater good of the medical field or for political/financial needs?
3.) Would having a new commissioner cause an uproar of current regulatory processes?

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