This predicate selection webinar explains the step-by-step process for conducting predicate selection as part of your 510k submission.
Please submit comments to the FDA regarding the new FDA draft guidance on best practices for predicate selection
On September 13, 2023, we prepared a blog discussing the new FDA draft guidance for predicate selection best practices. We have specific recommendations for changes to this draft guidance. We want to encourage others to voice their opinions as well. Therefore, we are providing several links for you below:
We published our redlined draft and it is available for download using the blue button above. If you would like to make edits and submit your own redlined version you can start with our redlined version or the original (i.e., green button). The FDA has a webpage with tips on how to respond to the guidance with comments and feedback. The deadline for submission of comments is December 6, 2023 @ 11:59 pm EST.
What is included in the 510k predicate selection webinar?
September 20, 2023, we are hosting a live and updated version of our predicate selection webinar (recording will be available afterward). This is one of the 58+ webinars that comprise our 510k Course that is available as a bundle for sale. The webinar now includes updated elements from the new FDA draft predicate selection guidance. The expected duration of the webinar is just over 1 hour. There were 28 slides in the updated presentation, and we will demonstrate how to use the following FDA databases:
A new software tool will be demonstrated as another method of searching for potential predicate devices instead of relying only upon the FDA database. That software tool is licensed from Basil Systems, and the ability of the software to automatically create a “predicate tree” and provide quick access to all of the potential 510k summaries within a product classification is impressive. We will cover strategic considerations when selecting a predicate device for your 510k submission. We will demonstrate how to enter your predicate selection into the new FDA eSTAR templates, and we will identify all of the locations in a 510k submission where your chosen predicate is referenced. If you are unable to identify a suitable predicate selection for your 510k submission, then you have five options.
What is a predicate device?
The premise behind the FDA 510k regulation is that your new device is substantially equivalent to another device (i.e., a predicate device) that is already on the market. Therefore, you only need to submit a premarket notification to the FDA instead of a premarket approval (PMA) submission. Most 510k submissions reference a similar device manufactured by a competitor, and as long as your device is similar to the predicate device, the matter of predicate selection is given little additional thought. There may only be one predicate device to choose from, or there may be hundreds of potential predicate devices.
510k Predicate Selection Webinar – $64.50
If you purchase one or more of the 510k course webinars and you decide to upgrade to the full course, we will issue a credit for previous purchases toward the 510k course. Please contact Rob Packard or Becca Taylor by email with a list of your previous purchases in the bundled course.
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 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 certification. From 2009-2012, 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 802.258.1881 or by email. You can also follow him on Google+, LinkedIn or Twitter.