美国FDA 指导原则 供CDRH和工业界使用的PMA第100天会议互动程序指南和后续不足之处(PDF格式) 英文原版.pdfVIP

Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies – for Use by CDRH and Industry This document is intended to provide guidance. It represents the Agency’s current thinking on the above. It does not create or confer any 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. PMA Staff, Office of Device Evaluation