美国FDA 指导原则 根据21 CFR 1271.15(b)关于例外范围的问题和答案的相同外科手术例外.pdfVIP

Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception Guidance for Industry Additional copies of this guidance are available from the Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Avenue, Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002 or by calling 1-800-835-4709 or 240-402-8010, or email ocod@, or from the Internet at /BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guid ances/default.htm. For questions on the