The FDA, in drafting the rule to ease the burden on small entities, has not applied the design requirements to all Class I devices and component suppliers have been removed from the rule's coverage.
Component suppliers are covered by the FDA.
mnli hypothesis: Component suppliers are covered by the FDA. premise: The FDA, in drafting the rule to ease the burden on small entities, has not applied the design requirements to all Class I devices and component suppliers have been removed from the rule's coverage.