Regulation (QS) for Medical Devices: General regulation (21 CFR part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions.

• 对医用装置的规定有：总规定（联邦法规全书第21章820条）和“食品和药物管理局”通过定期检查所确认的事项。