Alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical: 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, June 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Products -- standards Blood Platelets Government Regulation Platelet Transfusion Refrigeration United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- FDA (we) is issuing this guidance to provide a notice of exceptions and alternatives to certain requirements in Title 21 of the Code of Federal Regulations (CFR) regarding blood and blood components. This notice is being issued under 21 CFR 640.120(b) to respond to a public health need and address the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available, or their use is not practical. Maintaining platelet availability in the face of logistical challenges (e.g., in military, prehospital, or austere settings) or other threats to blood availability (e.g., mass casualty events or public health emergencies) is critical to assure that platelets are available to patients with active bleeding. Additionally, the guidance provides recommendations to blood establishments for the manufacture and labeling of cold-stored platelets (CSP). The guidance also discusses the need for additional data on the efficacy of CSP, in particular, to address whether their use is supported when conventional platelets are available, and their use is practical. For the purposes of this guidance, conventional platelets include all platelets (as defined in 21 CFR 640.20) intended for transfusion and stored at 20 to 24°C. Conventional platelets are also referred to as room-temperature platelets (RTP). Platelets stored continuously at 1 to 6°C within a specified time after collection are referred to in this guidance as CSP. 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, 13 pages))
- NLM Unique ID:
- 9918662988406676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918662988406676