The Advocacy Committee proactively identifies regulatory, reimbursement and practice challenges affecting the International Clinical Cytometry community’s ability to deliver patient care in all geographies.
The Advocacy Committee alerts ICCS and its associated clinical flow cytometry societies to these issues, and invites them in turn to alert The Advocacy Committee similarly.
When possible and appropriate, the Advocacy Committee and ICCS membership will engage with stakeholder groups and agencies in order to provide expert guidance in the area of clinical flow cytometry to thereby ensure patient access to this crucial diagnostic modality.
A draft guidance for cytometers and flow cytometric assays directed at industry and FDA staff was published in October, 2014. As ICCS members are also stakeholders in this document, the Advocacy Committee drafted a comment letter and encouraged members to submit their own letters. A total of 25 comments were received (as per the regulations.gov website) but they haven't been posted publicly. We'll update this notice as information becomes available.