CDRH Releases First Guidance on Heart Valves in 16 Years

Makers of replacement heart valves finally have CDRH’s thinking on preclinical and clinical studies to support investigational device exemptions and PMA applications for their products. CDRH last issued guidance on the devices in 1994, but that draft was withdrawn in 2005, the year the International Organization for Standardization (ISO) released its standards for cardiovascular implants and heart valve prostheses. The draft guidance CDRH issued recently is intended as a complement to ISO 5840:2005. Comments on the draft are due by April 20.
Devices & Diagnostics Letter