The US market, represents more than 40% of the global market for medical devices. Yet for many manufacturers, the process of obtaining clearance from the US FDA can be daunting. In this one hour webinar, we will demystify the FDA device clearance process, breaking it down into understandable steps and explaining each one. Here is what we will cover:
- Overview of the US medical device classification scheme
- What is Post Market Notification 510(k)?
- Do you have a predicate device with the SAME intended use?
- How to determine proper classification and Product Codes for your device
- Major sections of the FDA 510(k) application
- Common mistakes made during the 510(k) preparation process
- Discussion about FDA guidance documents and testing requirements
- Compliance with FDA Good Manufacturing Practice (21 CFR Part 820)
- Appointing a US Agent for non-US companies
- Establishment Registration process with the US FDA
- Fees and timelines
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