FDA and industry experts are coming together to review the basics of 510(k) submissions. This unique opportunity will help you better understand the FDA perspective on 510(k) submissions, from processes to approval to modifications. Throughout the 2-day workshop, you'll obtain actionable insights and strategies for assembling and streamlining an effective 510(k) submission.
Agenda topics include:
- Guidance for 510(k): general & product specific
- Different types of 510(k)s
- Considerations for determining a product's regulatory route to market
- Factors to consider when planning and assembling a 510(k) submission (staff involved, RA responsibilities, etc)
- Tips and hints on interacting with FDA during the 510(k) review process
- Deciding when to submit a new 510(k) for a device modification
- And more!
AdvaMed Coronavirus Precautions
AdvaMed is closely monitoring the international outbreak of a respiratory illness caused by a coronavirus first identified in Wuhan, China (COVID-19). According to the Centers for Disease Control and Prevention (CDC) as of February 26, the immediate risk of this new virus to the American public is believed to be low at this time; however, the AdvaMed team has increased precautionary measures, training, and communication.
The number one priority for AdvaMed’s Events and Education team is the health and safety of our event participants. We are diligently following releases and guidelines from public health agencies, including the CDC and World Health Organization (WHO), and will take measures at our upcoming events to increase sanitization efforts and minimize the spread of germs.
While attending our events, we ask you to practice general flu prevention, including:
- Cover your cough or sneeze with a tissue or sleeve
- Wash your hands regularly
- Avoid touching your face
- Avoid close contact with people who are sick
- Get your flu shot – it’s never too late
- Stay home if you are feeling ill; call your doctor to let them know your symptoms and travel history
For more information on COVID-19, please visit the CDC. If you have any questions regarding AdvaMed events, please contact firstname.lastname@example.org (link sends e-mail).
AdvaMed Member Registration: $1395.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $1,895.00
Note: Early-bird pricing is available for AdvaMed Members and Non-Members. Register now for $200 off your registration!