Why you should register for the Redacted FOIA 510k Webinar
For years I have been trying to identify what testing data was provided by other manufacturers in their 510k submission so that I can advise my clients regarding which predicate to select for a 510k submission. The four sources of information I used (until this week) were:
- the 510k Summary
- the product classification webpage
- special controls guidance documents
- recognized standards related to the device
There are two other sources that I used:
- redacted 510k submissions requested as per 21 CFR 807.93 (i.e., 510k Statements)
- redacted 510k submissions requested through the Freedom of Information Act (i.e., FOIA)
In the past, my primary method of obtaining more information was to request redacted 510k submissions directly from companies that had submitted a 510k Statement instead of a 510k Summary. These companies are required to provide a copy within 30 days. Recently the FDA made redacted 510k submissions that have already been requested available on the FDA website. Therefore, this is now my primary method of learning information about potential predicates.
In this webinar I will teach you how to get the most out of this new on-line database, and how to build your own 510k library of devices marketed by your competitors. These competitor 510k submissions are redacted, but you can still learn a lot more from the redacted submissions than you could from a 510k summary.
If there is a specific 510k submission that you want to review and the 510k is not currently available on-line, you can also submit a FOIA request on-line. I review this process during the webinar and I provide a template for submitting FOIA requests. The application process takes less than 5 minutes.
What you will receive for $79
- a recording of the webinar you can replay anytime
- the most recent version of my FOIA request form template
- the native slide deck for this webinar
There are 29 slides during the presentation. The presentation is 48 minutes in duration–including the Q&A session from the live presentation. All deliveries of content will be sent via AWeber emails to confirmed subscribers.
Redacted FOIA 510k Webinar – $79
In this webinar you will learn how to use the new Redacted FOIA 510k Database on the FDA website in order to find more information about testing that was performed for potential predicate devices.
- FDA eCopy Print & Ship Webinar – Free if you submit a question
- FDA Form 3654, Declaration of Conformity – $49
- 510k Boilerplate Webinar – Free if you submit a question
- How to Complete Your 510k Cover Letter – $29
- UDI-Labeling Requirements Webinar – $49
- Device Description Webinar – $29
- 510k FAQs Webinar – Free if you submit a question
- Small Business Qualification Webinar for 510k Submissions – $29
- 510k Hardware Software Documentation Webinar – $129
- 510k Project Management – Lessons Learned – $129
- De Novo Application – $49
- How to Combine a 510k Submission with CE Marking and Reduce Your Workload by 35% – $129
- FDA Pre-Sub Meetings – $129
- 510k Submissions: Predicate Device Selection – $129
- 510k Submissions: Substantial Equivalence – $129
- 510k Submission Section 4: Indications for Use – $129
- 510k Project Management Webinar – $129
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years 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 802.281.4381 or email. You can also follow him on Google+, LinkedIn or Twitter.