Complex medical devices must be proven safe before the fda will allow them to be sold in the us.

That statement is true The Government created this regulation to prevent any form of malfunctioning medical device that would potentially bring harm to the buyer. The medical devices that approved by FDA has passed several research and testing to prove its function

True because everything that is regulated has been tested thouroughly to be sold in stores

Nothing will delay it, but drinking some lemon (squeeze 3) would cut it, making it last a few days, but its not good to do that. won't hurt you but the next month will be more cramps.. take some advils with you on the trip