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Dd Form 2970

Dd Form 2970

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now that we understand the basics of these two Pathways let's talk about a little more strategic issue sometimes a company will want to explore two different clinical areas for a product for example different areas of surgery how would a company approach the FDA in this situation well there are a number of choices that a company could follow you can ask for all of the indications in one time but that becomes complicated it may result in a bigger study it may be more costly and it may in some instances overwhelm the FDA reviewers because there's so many different issues that they're looking at so in in a number of situations companies will use a platform or stepwise approach to seeking clearance or approval for their devices depending upon whether it's a 510k or PMA so you would start with a basic application and then build on that initial clearance or approval through subsequent applications and changes that you make to the device in new generations of t

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