Why you should register for the FDA Form 3654 Webinar
If you are missing a Declaration of Conformity for one of the recognized standards applicable to your device classification you will receive an RTA hold letter from the FDA and this will delay the FDA’s decision of Substantial Equivalence by two weeks–plus the amount of time it takes you to supplement a supplement to your original submission with a completed FDA Form 3654 for each of the applicable standards you forgot.
In this webinar you will learn:
- How to complete FDA Form 3654
- How to identify which recognized standards the FDA will be looking for
- How to look-up the FDA recognition number
- How to make sure that you have identified the most recent revision of each standard
- What to do when you realize that the standard you tested to is obsolete
- How to answer each of the questions on the first page of FDA Form 3654
- How to complete the summary report on page 2
- What to do when you don’t have enough pages to create a summary report with FDA Form 3654
You will even learn how to look up examples of completed FDA Form 3654 for predicate devices using the new “Redacted FOIA 510k” Database.
What you will receive for $49
- a recording of the webinar you can replay anytime
- a blank FDA Form 3654
- my updated template for the Declaration of Conformity Overview document
- the native slide deck for this webinar
There are 28 slides during the presentation. The presentation is 45 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.
FDA Form 3654 Webinar – $49
In this webinar you will learn how to complete FDA Form 3654 in order to identify which recognized standards are applicable to your 510k submission in order to pass the RTA screening process.
- 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.