<prompt> Translate the following text to EnglishFDA, katika kuunda sheria ili kupunguza mzigo kwa mashirika madogo, haijaweka mahitaji ya kubuni kwa vifaa vyote vya darasa la I na wauzaji wa sehemu wameondolewa kutoka kwa chanjo ya sheria.  <response>: 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 rules coverage. 