Udemy - How to Market Medical Devices in the U.S.
Size: 157MB | Duration: 0h 40m | Video: AVC (.mp4) 1280x720 30fps | Audio: AAC 44.1KHz 2chGenre: eLearning | Level: Intermediate | Language: English
Register with the FDA
Understanding the FDA's regulatory system is the first objective for device manufacturers looking to sell in the U.S. The 510(k) Premarket Notification submission should be prioritized when developing a medical device. This pathway provides marketing clearance and the ability to sell your medical devices in the U.S. Before sales can occur companies have two options: 510(k) Premarket Notification (unless exempt); or Premarket Approval (PMA) approval. PMA's are resource intensive, and so 510(k)'s are the ideal submission type.
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