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What is the difference between a 510k and De Novo?

Most people think the difference between a 510k and a De Novo is time and money. That conclusion is based upon a very important assumption: a 510k will not require clinical data and a De Novo will require clinical data. That assumption is not always correct. 10-15% of 510k submissions include clinical data to support the performance claims, and last year our team submitted three De Novo submissions that did not include any clinical data. So what are the real differences between a 510k and a De Novo? We use the same FDA eSTAR template for both types of FDA submissions, and on the first page of the eSTAR template we identify if the submission is a 510k or De Novo. If we select De Novo, the eSTAR will be pre-populated with four unique content requirements that are not found in a 510k. The four unique requirements are: 1. identifying alternative practices and procedures for the same indications 2. recommending a classification, providing a justification for that classification, and explaining what efforts were taken to identify a suitable 510k product code 3. providing a written benefit/risk analysis starting with the clinical benefits of your device 4. recommendations for special controls for your new product code based upon the risks to health and the mitigation measures for each risk If you would like to learn more about these four differences, please visit our new blog on this topic: https://medicaldeviceacademy.com/de-n... Timestamps: 0:00 An incorrect assumption 1:03 Alternate practices and procedures 1:50 Classification 2:21 Benefit/Risk Analysis 3:47 Special Controls