美国FDA 指导原则 便利包临时监管指引(PDF格式) 英文原版.pdfVIP

Convenience Kits Interim Regulatory Guidance This document is intended to provide guidance regarding a new premarket notification regulatory strategy for convenience kits. 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. Public input on this document was not obtained prior to implementation because it is believed that this guidance presen