Monday Chronicles with Lindsey and Rob.

Lindsey Walker is our director of sales, and two clients asked her the same question last week: "When is it too early to create a regulatory pathway?" The answer is that it's never too early. You should know your regulatory pathway before you start raising any money, because you need to be able to tell investors how much it is going to cost to develop your product and how long it will take to get through the FDA.

Later in the video, Lindsey asked, "If somebody thinks they need to submit a De Novo, should they submit a 513(g)?" Rob explained two worst-case scenarios where the FDA thought the device required a De Novo and then changed their mind. In both cases, the company only did a pre-sub and elected to skip the 513(g) submission. In a 513(g) we are only required to submit a device description, labeling, and instructions for use. However, we now recommend that companies also include the following documents in the 513(g) to ensure the FDA gives the right answer:
1. classification rationale as Class 1 or 2
2. a proposed regulation name and number
3. proposed special controls
4. draft benefit/risk analysis
5. risk mitigation table
6. alternative procedures and techniques to the subject device's technology
7. your efforts to identify a potential predicate device

Timestamps:
0:00 - When is it too early to create a regulatory pathway?
4:29 - If somebody thinks they need to submit a De Novo, should they submit a 513(g)?
5:45 - Minimum requirements for a 513(g)