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医疗产品的管理需要科学的方法。FDA重视采用风险管理的方法对医疗产品进行分类监管。FDA有多个部门对医疗用品进行监管,如药品评价研究中心(CDER),器械和辐射健康中心(CDRH),生物制品评价研究中心(CBER)等。医疗产品从上市前许可到上市后监管和再评价,都是由多个部门协作进行产品风险管理。
The management of medical products requires a scientific approach. FDA places emphasis on the use of risk management methods for the classification of medical products supervision. FDA has multiple departments that regulate medical supplies such as CDER, CDRH, CBER and others. Medical products from pre-market permission to post-market regulation and re-evaluation, are coordinated by a number of departments for product risk management.