Emergency Use Authorization (EUA)
Owing to the Covid-19 pandemic there has been a surge in demand for Medical devices (Diagnostic Devices, Blood Purification Devices, Ventilators, Lung therapy Systems) and Infectious disease test kits. Considering this, the FDA has given the Emergency Use Authorization (EUA) to over 120 Companies which either allow an unapproved medical product or the unapproved use of an approved medical product to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions as Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
However, as and when the need goes away, the FDA withdraws the EUA. This creates a need for all the OEMs who have put their products in the market with EUA, to get their products approved through the regular approval route to ensure product continuity. LTTS’ FDA EUA to 510K Transition Service is created to support the OEM’s through the transition.
EUA to 510K TRANSITION SERVICES
Documentation
- IFU
- Labeling
- Justifications/Memos
- Tech file creation – DHF and Summary
- Risk and Hazard files
- Complaint Analysis
Valid Scientific Evidence Covering
- Performance testing- Bench, Simulated
- Support Bio-compatibility testing
- Stability/Shelf life
- Usability testing
- Clinical evidence- Literature reviews
- Support Sterilization validation
- Compliance testing
Manufacturing & Supply chain Services
- Line validation – IQ, OQ, PQ
- Supplier evaluation and qualification
Benefits
Faster Time to Market
LTTS performs the documentation activities concurrently and our experience with FDA 510 K filings ensures faster Filing and GTM
Free up Bandwidth
LTTS acts as an extended arm of the client for the transition activities related to technical documentation and valid scientific evidence covering, hence freeing up the bandwidth for the customers
Cost savings
LTTS performs the transition activities remotely from its offshore delivery centers which result in significant cost savings for the customers
Resources
Stay Compliant Beyond EUA
Owing to the Covid-19 pandemic there has been a surge in demand for Medical devices and Infectious disease test kits. Considering this, the FDA has given the Emergency Use Authorization (EUA) to ove...
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