FDA 510K
Change in submission format - eSTAR
The FDA has introduced eSTAR to replace the traditional 510(k) submission. eSTAR stands for the US FDA Electronic Technical Submission Form and will be mandatory from 1 October 2023.
The 510(k) approval process, overseen by the U.S. Food and Drug Administration (FDA), is a pathway for medical device clearance in the United States. It allows manufacturers to demonstrate that their new medical device is substantially equivalent to a legally marketed device (a "predicate device") with similar intended use and technological characteristics.
To gain 510(k) approval, manufacturers must submit a detailed application that includes information about the device, its intended use, its technological features, and a comparison to the predicate device. The FDA reviews this submission to determine if the new device's safety and effectiveness are on par with the predicate device. The goal is to ensure that new devices do not present additional risks or uncertainties to patients and healthcare providers.
The 510(k) process expedites market entry for devices by leveraging prior knowledge about similar devices, which means that clinical trials are generally not required. However, the level of data and evidence required depends on the complexity of the device and its potential risks. The FDA's decision is based on a thorough evaluation of the provided data and any potential concerns raised during the review.
Once the FDA grants 510(k) clearance, the manufacturer can market and distribute the device in the U.S. This process contributes to a balance between timely access to innovative medical technologies and patient safety, as devices with a substantial equivalence to established predicates are more likely to be safe and effective.
In summary, the 510(k) approval process is a pathway through which manufacturers can introduce new medical devices to the U.S. market by demonstrating substantial equivalence to existing, legally marketed devices. This process helps ensure patient safety while facilitating the availability of innovative medical technologies.
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