Fundamentals of FDA Medical Device Regulations

  • Presented by: Beth Luoma
  • On: January 17, 2018 at 12:01AM
  • Category: Webinars
So you think you might have a medical device… Does FDA regulate your device? Do you need FDA approval before you can sell it? What else do you need to know to be FDA-compliant? This free webinar covers the fundamentals of FDA medical device regulations. Key topics include: The definition of “intended use” as it relates to “medical device” The classification system for medical devices The most common regulatory pathways for marketing medical devices: 510(k) and PMA The content of this webinar is geared towards those with little to no experience in FDA and medical devices. The targeted audience includes inventors, physician-inventors, engineers, software developers, and anyone else planning or developing a product that may have a medical purpose. Register here: https://register.gotowebinar.com/register/4237778785522863618
Helping clients be appropriately aggressive, yet compliant. TM