Everything you Need to Know about SaMD from an FDA Perspective
Global Medical Device Podcast powered by Greenlight Guru
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Pre Submissions
The more you can get in front of FDA and familiarize them with your device early on, the more comfortable they're going to be later on when you're having the real interactions. Find an image that that FDA can lock in on and put that into a pre submission and make sure that image stays in future submissions. Don't hesitate to go peruse the FDA website and FDA has said in some recent guidance that just came out as well that they're still taking pre submission Q subs.
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