Want to save time doing research for 510(k) prep?
See how searching for FDA Clearances for 510(k) prep can be accomplished quickly in this brief, 3 min video. Within just a few clicks, you can find new predicates for a specific or similar device or research clearances with similar intended uses or indications for use.
Navigator is a one-of-a-kind solution, designed to aid in 510(k) research by:
- Quickly sort and filter results by decision date within the Past 5 or 10 years
- Provides full 510(k) details including FDA Product Codes, decision timeline, and supporting guidance documents
- View Predicates and applicable Successors to existing Clearances
- For ongoing monitoring, 510(k)s may be added to a Watchlist for event notifications
- 510(k) search includes Biologic 510(k)s and De Novos in a single search
Navigator for Medical Devices is a quick and comprehensive way to conduct searches for FDA Clearances and view 510(k) Predicates and Successors. Contact us at MedDevice@ReedTech.com for a customized demonstration and see how efficiencies are gained with Navigator.
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