美国FDA 指导原则 血压和脉搏捐赠者资格要求合规政策_2022年5月 英文原版.pdfVIP

Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy Draft Guidance for Industry This guidance document is for comment purposes only. Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit electronic comments to /. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register . Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., 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 /vaccines-blood-biologics/guidance-compliance- regulatory-information-biologics/biologics-guidances. For questions on the content of this guidance, contact OCOD at the phone numbers or email address listed above. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research May 2022 Contains Nonbinding Recommendations Draft – Not for Implementation Table of Contents I. INTRODUCTION 1 II. BACKGROUND 2 III. DISCUSSION 2 IV. DONOR BLOOD PRESSURE AND PULSE ELIGIBILITY REQUIREMENTS – CO