FDAnews Device Daily Bulletin

The International Medical Device Regulators Forum (IMDRF) has approved a draft document outlining standards for international recognition of groups auditing devicemakers, an FDA official who attended the group’s recent meeting in Sydney, Australia, said. “The document should be on the IMDRF.org website by the end of October for comment through the end of the year,” Kimberly Trautman, associate director of international affairs within CDRH, told D&DL.
Devices & Diagnostics Letter