Inventing New Products/Inventions/FDA approval


Hi Marty, I have developed a therapy product for pediatric patients.  My invention is not highly technical, it can be made from basic materials, but I don't think there is anything like it out there. I was hoping to get a provisional patent and test the waters before I make a big investment paying for a real patent. I want to make sure there is a following for my product. Would I need to get FDA approval on this? Any insight you could give me would be appreciated. Thanks!

Hi Elin,

You will not need FDA approval to make your prototype, and test it.  However you will need a provisional, full patent and FDA approval before you offer your idea for sale on the market.  I am assuming you need FDA approval because you brought it up.  Does your idea go into the human body in one form or fashion?  I would check with the FDA to be sure that you need approval on your particular idea beofre you invest time, effort and tons of money into your idea.

I hope this helps.

Happy Inventing!


Marty McCrea

Inventing New Products/Inventions

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Marty McCrea


Commercialization of an idea is truly an art form and I'm really good at letting people borrow my paintbrush. Although, it's important to note that you are your own artist, I can't paint what you see in your mind, only you can do that. But I can help. I can answer questions about honing your idea and helping it to become more real in your mind, your research, and within your speaking. I can answer questions about market research, validation, and where to go to make your first contact. My expertise is in answering the large questions that you have into more manageable pieces. I can also assist you in finding the source of the data that you can use to prove and pitch your idea if that's the path that you're on.


In my opinion, the current way to invent is inherently flawed. Regular people like us normally get “eaten up” by the proverbial sharks in the water. (corporations, invention submission companies, lawyers, etc)

We can not stand for this any longer; you feel this too, yes?


I have helped people think and re-think their ideas for years. Nobel Prize Winner Albert von Szent-Gyorgyi once said that "Discovery consists of seeing what everybody else has seen, and thinking what no one has thought." I agree with this truth with all of my heart. Now let's talk about your question, your passion, and how I can help your idea gain momentum if it is ready. If your idea is not ready for the market yet, I'll help you determine how you can get ready.

Bachelors of Arts in Organizational Communication from the University of Northern Iowa Masters of Science in Technology Commercialization from the McCombs School of Business at the University of Texas at Austin

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