Every single day matters! – Elexes
Elexes Medical Consulting

When companies are looking to get their product to the market, they certainly want to get it there as soon as possible. What approach can help with that:

1. Build a clear regulatory pathway to get the product to the market

2. Preemptively assess areas of potential hurdles for marketing approval

3. Pursue pre-approval applications; there are many like, pre-sub, breakthrough

4. Get an agreement on the solutions you propose to the potential hurdles

5. Understand the timeline that the FDA or the target regulatory body works with

6. Prepare the application in such a way that there are least questions from the FDA

The time frame for a typical 510k is shown below. All the days are the FDA days, that is the time the agency takes to review, approve, send questions, etc. Knowing about these simple steps, a lot of time can be saved; and your device can get through the FDA approval process within a stipulated time frame.

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