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July 11, 2023
John Rizvi, Esq.

Should I Get FDA Approval for My Medical Device Invention Idea Before I File a Patent Application?

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00:06

Adrian would like to know, “Do all medical devices have to be approved by the FDA before I can get a patent?”

No, no, in fact, there's no relation between FDA approval and, and the patent office’s approval. So there's, you know, there's a, it's probably beyond the scope of this webinar as to what medical devices need FDA approval and which ones don't. But you absolutely do not have to have FDA approval before you can file for a patent. I mean, the typical route that I would recommend, because FDA approval takes years and years and years. And if you don't file for your patent, while you're waiting for that approval, somebody else could file the patent first. And in 2013, that's been the single biggest change in patent law in this century, is that the US moved from a First-to-Invent to a First-to-File system. So today, whoever follows the patent first, they own the idea, and that's going to be key is getting that patent in as soon as possible. So I wouldn't let FDA approval hold back your patent process.

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