REGULATORY UPDATE: New AABB Toolkit Outlines Implementation Options for FDA’s New Blood Pressure and Pulse Compliance Policy

AABB has developed a toolkit of options for implementation following the issue of FDA’s new compliance policy guidance on donor blood pressure and pulse requirements.

As described in a recent Weekly Report article, the compliance policy allows for greater flexibility in responsible physicians’ medical oversight of blood pressure and pulse donor eligibility determinations. The guidance outlines the circumstances in which FDA does not intend to take regulatory action for a blood establishment’s failure to comply with certain regulations for determining the eligibility of blood donors with blood pressure or pulse measurements outside of specified limits.

The toolkit is intended to help facilities identify flexible options as they consider compliance and implementation strategies that meet the unique needs of their establishments.

Those with questions may contact regulatory@aabb.org.