What is a 510(k)?
In order to market a medical device, manufacturers must comply with the 510(k) section of the Food, Drug and Cosmetic Act.* This requirement states that device manufacturers must register and notify the FDA minimally 90 days in advance of their intent to market a medical device. Known as Premarket Notification – also called PMN or 510(k), this step signifies that a determination must be made to qualify the device as equivalent to a device already placed into Class I, II or III categories. For devices that are intended to be first-time market entrants for commercial distribution or devices that have undergone significant changes or modifications, a Premarket Notification is required. Any changes related to intended use, design, materials, chemical composition, process for manufacturing or source of energy; basically anything that could impact safety requires PMN. See more from the FDA about 510(k) Clearances here.
How to achieve better regulatory intelligence and 510(k) prep when searching for FDA clearances?
The answer to 510(k) Research – Reed Tech Navigator™ for Medical Devices was created to aid in the 510(k) process and has made over 65,000 510(k) PDFs searchable by intended use, indications for use, and device description.
Navigator is a one-of-a-kind solution, designed to aid in 510(k) research by:
- Enabling quick research for clearances with similar intended uses or indications for use
- Finding new predicates for a specific or similar device in just a few clicks
- 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 for a customized demonstration and see how efficiencies are gained with Navigator. Thank you for providing contact details in the brief form below.