Phelps J R
Med Instrum. 1980 May-Jun;14(3):144-8.
The Medical Device Amendments of 1976 erected the framework for the most complete regulatory scheme administered by the Food and Drug Administration. The FDA has fulfilled its charge to establish investigational device exemption regulations, recordkeeping requirements, and informal hearing procedures. The author concludes that (a) technological innovation will come in a climate of step-by-step FDS involvement, (b) recordkeeping requirements will be focused to maximize the agency's power to take regulatory action, and (c) the hearing mechanism for judging many significant agency regulatory actions will be in the hands of FDA employees who will be free to operate with almost no rules of evidence to constrain them.
1976年的《医疗器械修正案》建立了由食品药品监督管理局管理的最完备监管体系的框架。美国食品药品监督管理局已履行职责，制定了研究性器械豁免规定、记录保存要求和非正式听证程序。作者得出结论：(a) 技术创新将在食品药品监督管理局逐步参与的环境中出现；(b) 记录保存要求将集中于最大限度地增强该机构采取监管行动的权力；(c) 用于评判许多重大机构监管行动的听证机制将掌握在食品药品监督管理局员工手中，他们在几乎没有证据规则约束的情况下可以自由操作。
