A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, “substantially equivalent”, to a marketed device. For devices that are low to moderate risk but are found to be “not substantially equivalent” to a predicate device, the de novo classification process provides a possible route to market.
Recently, the FDA released details of medical devices that have been approved through the de novo review pathway. These details included public access to FDA approval letter and decision summary. For detail, the summary is intended to:
- Present an objective and balanced summary of the scientific evidence that served as the basis of the decision to grant a de novo petition
- Specify how FDA determined that the device for which a petition is granted is low to moderate risk and that general and/or special controls provide reasonable assurance of safety and effectiveness
- Serve as a resource on the types of information necessary to support substantial equivalence for device manufacturers that may wish to use the de novo device as a predicate for future 510(k) submissions
After glancing at some of the summaries it seems as if the FDA is aiming for increased transparency as well as giving industry examples of its processes.
What are your thoughts on having the approval letters and decision summaries available for public access? Share you thoughts in the comment portion below.
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