The US remains the largest medical device market in the world but gaining regulatory approval from the FDA is not fast, cheap or easy. In this one hour webinar, we demystify the process and explain what you need to do before starting your 510(k) submission, what the FDA wants to see, and how to avoid problems that delay or derail submissions. In this webinar recorded in July 2017, we cover:
- Brief overview of the US regulatory process
- Classification scheme
- How the FDA uses product codes and regulation numbers
- Role of guidance documents and types of documents
- Testing and how to find out what your device requires
- Document structure of a 510(k) submission
- The "Refuse to Accept" (RTA) process – how it works
- Additional Information (AI) requests and following up with FDA reviewers
- Common mistakes and how to avoid a quagmire
- Average time to clearance for specific types of devices
DOWNLOAD PDF OF FDA 510(K) WEBINAR SLIDES (opens new window)
ABOUT THE PRESENTER:
Audrey Swearingen is Director of Regulatory Affairs at Emergo's Austin, Texas headquarters. With over 20 years of experience in regulatory affairs, Audrey's areas of expertise include US FDA, European and Canadian medical device registration.