FDA Issues First Device 'Close-Out' Letter; Experts Weigh In On Details

THE FIRST QUALITY-RELATED DEVICE 'CLOSE-OUT' LETTER was sent by FDA to manufacturer Z-Medica on March 1, officially closing out a December 2009 warning letter that cited the firm for four violations of the Quality System Regulation. Z-Medica's close-out letter came surprisingly fast, given initial expectations from CDRH's Office of Compliance that close-outs could take up to a year. How quickly future close-out letters are issued depends on the specific violations and whether a follow-up inspection is needed, said Larry Spears, deputy director of regulatory affairs in the compliance office. Attorneys debate whether Z-Medica deserved the close-out letter and whether the contents were sufficient. Z-Medica explains how it fixed its quality problems and gained resolution with FDA in less than five months