Compliance policy regarding blood and blood component donation suitability, donor eligibility and source plasma quarantine hold requirements: guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Blood Banking -- standards Blood Donation -- standards Blood Donors Donor Selection -- standards Government Regulation Guideline Adherence Plasma United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- This guidance addresses certain requirements that apply to blood establishments that collect blood and blood components, including Source Plasma. Specifically, the guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment’s failure to comply with certain requirements in Title 21 of the Code of Federal Regulations 630.30 (21 CFR 630.30) regarding donation suitability; 21 CFR 630.10(c)(2) regarding donor eligibility; and 21 CFR 640.69(f) regarding quarantine hold for Source Plasma. This guidance finalizes the draft guidance of the same title, dated May 2022, and supersedes the guidance entitled, “Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency; Guidance for Industry,” dated April 2020. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (i, 7 pages))
- NLM Unique ID:
- 9918732188406676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918732188406676