7 Day Dating FAQs

Apheresis bags for platelets suspended in 100% plasma from Fenwal, Terumo and Haemonetics are currently cleared for 7 day storage.

If you are an FDA registered site you simply need to create an SOP, determine how you are going to label the platelets with the new extended date, notify the FDA that you are moving to 7 days via an FDA Form 2830 and implement Safety Measure testing.
If you are not registered, simply register with the FDA and do the above.
It you are an FDA licensed site you must file your SOP and labeling with FDA for review and approval.

No, the FDA has already cleared and cross labelled bags for 7 day storage and a Safety Measure test for platelet dating extension. They can be used to extend platelet dating to 7 days now without the need for Guidance.

Only if you are a licensed blood establishment. FDA Registered sites only need to notify the FDA by filing a form 2830 indicating they are testing for 7 day platelets.

Only if you are licensed blood establishment. FDA Registered sites only need to notify the FDA by filing a form 2830 indicating they are testing for 7 day platelets.

No. You simply need to test a platelet once on either day 6 or 7 within 24 hours of transfusion with a Safety Measure.

The blood center label does not change. You can test any 5 day labeled apheresis platelet in 100% plasma in an approved storage container and relabel it for 7 days.

Yes.

Yes, but only within your state. If you want to ship outside your state you must be an FDA licensed facility.

Not at this time. The manufacturer of the storage container would have to obtain FDA clearance for 7 day storage in order to do that.

Not at this time. The manufacturer of the storage container would have to obtain FDA clearance for 7 day storage in order to do that.

Not at this time. The manufacturer of the storage container would have to obtain FDA clearance for 7 day storage in order to do that.