The client is a leading manufacturer of Laryngoscope and is located in USA. The client was planning to re-list the class I device in FDA FURLS (Unified Registration and Listing System)​. With a short TAT, Freyr had to check the label as per latest 21CFR801 requirements and the amount of label to be analyzed was extensive.

Read through this case to decode how Freyr efficiently addressed the gaps of the labeling within the stipulate time.