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.
The FDA will include component suppliers in their coverage in the future.
mnli hypothesis: The FDA will include component suppliers in their coverage in the future. 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.