The US Food and Drug Administration published two draft guidances and a revised final guidance that relax its regulatory oversight of blood and blood component donations. The agency says the changes make it easier for donation centers to receive blood while not significantly increasing risk to donors and patients.
On 23 May, the Center for Biologics Evaluation and Research published two draft guidances titled Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements, and Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy. The guidances would permanently apply regulatory discretions FDA instituted at the start of the COVID-19 pandemic to ensure there wasn’t a shortage of blood and blood components.
The first draft guidance would permanently apply regulatory discretion to the April 2020 guidance titled Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency. Since, issuing the guidance the agency says it has concluded the steps it took to reduce regulatory requirements have not significantly increased risks to donors or recipients and encouraged it to make those measures permanent…
