This webinar will teach you about the Dual 510(k) and CLIA waiver submission options using the FDA eSTAR template.
Dual 510(k) and CLIA Waiver Webinar ($79)
When is the Dual 510(k) and CLIA Waiver Webinar?
This webinar will be live on Thursday, February 15, 2024 @ 10:30 am ET. The session will also be recorded. You can purchase it on-demand and watch the training as often as you wish.
Why you should register for the Dual 510(k) and CLIA Waiver Webinar
You will learn the requirements for a CLIA waiver and the dual submission of a 510(k) and CLIA waiver. The webinar will also demonstrate how to include this information in your FDA eSTAR submission. Slides 2-18 of this webinar are specific to the CLIA waiver requirements that are applicable to CLIA waivers even if you do not submit a dual 510k and CLIA waiver. Slides 19-26 are specific to the dual 510k and CLIA waiver submission requirements. The presentation includes training on study design, human factors testing, labeling, and flex studies.
What you will receive
- an invitation to participate in the live webinar (if you purchase prior to February 15)
- a recording of the webinar you can replay anytime
- the native slide deck for this webinar (28 slides)
- training on how to apply the CLIA waiver guidance from the FDA
- training on how to apply the Dual 510(k) and CLIA waiver guidance from the FDA
- copies of three different FDA guidance documents related to CLIA waivers
If you would like to ask specific questions about preparing the dual submission of a 510(k) and CLIA waiver, please submit them via email or schedule a call using the calendly app on our contact us page. All deliveries of content will be sent via AWeber emails to confirmed subscribers. If you don’t receive the content automatically, please check your spam folder.
Additional Resources for 510k submissions
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.