FDA Final Guidance Psoralen Platlets

[bldbnkr 44]

Hi Blood Bankers,

Rumor has it that the FDA has issued Final Guidance for the Psoralen pathogen inactivated platelets.  Has anyone seen a copy?

 

Maryann

[tcoyle 56]

As far as I know, FDA currently has a draft guidance for pathogen reduced platelets.  FDA recently came out with the final regarding bacterial risk and platelets.

You can search for FDA guidance's any time.  Copy this link             https://www.fda.gov/regulatory-information/search-fda-guidance-documents

 

 

 

[Marianne 65]

The final came out on Sept 20th, no longer a draft.  We have 18mths to implement.

Bacterial-Risk-Control-Strategies-for-Blood-Collection-Establishments_09-2019.pdf

[bldbnkr 44]

Thank you!

[Ally 6]

Yes, I  received the email from our supplier.