Abel Company wants to sell the vaccine delivery systems.  The Food and Drug Administration system issued a new rule (after notice and comment) to any vaccine delivery manufacturer stating that it had to have, prior to selling any systems, a $50 million insurance policy to cover the claims of persons who were harmed by the systems.   The FDA claimed that the rule is necessary because the law stated that medical devices must be safe and insurable up to the amount of the revenues of the Company.   Abel has revenues of $50 million, but can't afford to buy a policy like that, so it challenges the rule in court.     What is the likely ruling, and why?

Answer rating: 100% (QA)

The likely ruling in this case would be that the FDAs rule is invalid The rule requires vaccine deli... View the full answer