##  [Comprehensive Gap Analysis of the Labeling Based on 21CFR801](/index%2ephp/case-studies/comprehensive-gap-analysis-of-the-labeling-based-on-21cfr801) 

- [Medical Devices](/index%2ephp/case-studies-main-categories/medical-devices)
- [Quality, Compliance, & Audit (QMS)](/index%2ephp/case-studies-main-categories/quality-compliance-audit-qms)





[US FDA](/index%2ephp/case-studies-heath-authority/us-fda)

 

 ![Comprehensive Gap Analysis of the Labeling Based on 21CFR801]()

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 the FDA FURLS (Unified Registration and Listing System)​. Within a short TAT, Freyr had to check the label compliance as per the latest 21 CFR 801 requirements.

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



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