The following table outlines the FDA's standards and areas of jurisdiction.
Broad standards are relative for drugs and medical devices.
They weigh risks against benefits, permitting substantial risks when the benefits are also great. Enforcement of these standards is with pre-market review and certification, sample testing, surveillance, and remedy imposition. The drug approval process is subject to two types of errors. There is a Type I error , in which a drug is put on the market when it should not have been put on the market. There is also a Type II error , in which a drug is left off of the market when it should have been allowed on to the market.