America’s Blood Centers (ABC) has submitted comments to the U.S. Food and Drug Administration (FDA) regarding the draft guidance titled “Select Updates for the 506J Guidance: 506J Device List and Additional Notifications.” In the FDA 506J guidance comments, ABC urges FDA to include devices used for the collection of blood products on the 506J Device List noting the important role in public health of devices that are used for the collection of blood products, “[as they] ensure life-supporting, life-sustaining, and emergency blood products are available when needed.”
The FDA 506J draft guidance, “propose[s] select updates to the FDA guidance document ‘Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act’ (506J guidance) [and] provides a proposed list of devices, by FDA product code, for which a manufacturer of such devices is required to notify FDA in accordance with section 506J of the FD&C Act (506J Device List).” Through the draft guidance, the agency seeks to, “clarify that manufacturers may submit, and FDA may receive, voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a public health emergency.”
In the FDA 506J guidance comments, ABC explained how supply chain challenges in recent years have, “threatened the availability of a robust blood supply. The limited number of manufacturers of whole blood and apheresis collection sets licensed in the U.S., the limited number of manufacturing sites for blood bags and collection kits they operate, and the location of these sites in geographically vulnerable areas combine to pose significant concerns to the entire blood community. In addition, throughout the pandemic, blood centers experienced supply chain shortages of blood tubes, pipette tips, and personal protective equipment necessary for collecting and manufacturing blood components. Blood collectors took numerous steps to mitigate the impact of these shortages on patient care…These changes ensured continued availability of blood components to serve patients, however, they also resulted in increased costs, staff time, and increased complexity within blood center operations. While the tactics differed, ensuring a safe and adequate blood supply was always paramount.”
The FDA 506J guidance comments developed by ABC also provided the agency with a listing of devices used to collect products that should be included on the 506J list:
“Subpart F – Automated and Semi-Automated Hematology Devices:
- 864.5200 Automated Cell Counter {GKL};
- 864.5600 Automated Hematocrit Instrument {GKF}; [and]
- 864.5620 Automated Hemoglobin System {GKR}.
Subpart H – Hematology Kits and Packages:
- 864.7825 Sickle cell test {JBB}.
Subpart J – Products Used in Establishments That Manufacture Blood/Blood Products:
- 864.9050 Blood Bank Supplies (pipettes, blood grouping slides, blood typing tubes and racks, cold packs for antisera reagents) {KSS};
- 864.9100 Empty container for the collection and processing of blood and blood components {KSR};
- 864.9125 Vacuum-assisted blood collection system {KST};
- 864.9145 Processing system for frozen blood (for both freezing and thawing red blood cells) {KSW};
- 864.9175 Manual blood grouping and antibody test systems {PBC};
- 864.9195 Blood mixing devices and blood weighing devices {KSQ};
- 864.9245 Automated blood cell separator (apheresis devices) {GKT};
- 864.9275 Blood bank centrifuge for in vitro diagnostic use {KSO};
- 864.9575 Environmental chamber for storage of platelet concentrate {KSH};
- 864.9700 Blood storage refrigerator and blood storage freezer {KSE};
- 864.9750 Heat-sealing device (also sterile docking devices) {KSD}; [and]
- 864.9875 Transfer set. {KSB}.”
ABC will continue to provide updates on its advocacy efforts regarding the FDA 506J guidance comments. An archive of all letters and comments on ABC’s blood advocacy initiatives is available.