美国FDA 指导原则 测试非铰接式‘机械锁定’模块植入物组件的指导文件(PDF格式) 英文原版.pdfVIP

This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s. GUIDANCE DOCUMENT FOR TESTING NON-ARTICULATING, MECHANICALLY LOCKED, MODULAR IMPLANT COMPONENTS