Why you should register for the 510k Cover Letter Webinar?
A 510k Cover Letter needs to include the administrative information that is needed to properly identify you, your company, the 510k submission type, applicable regulations, product classification, the review panel, the device product code and any previous submissions related to this 510k submission. The 510k Cover Letter also includes a statement that your submission includes a paper copy and an eCopy. There are also specific questions that the reviewer needs answered about your product in order to identify specific specialists that may need to be involved, such as:
- Is the device provided sterile?
- Does the device contain a drug?
- Does the device use software?
- Does the submission include clinical information?
- Is the device implanted?
In addition to the 510k Cover Letter there is also a submission cover sheet that must be prepare (i.e., FDA Form 3514). The submission cover sheet includes details that are used to create a database entry for you, your company and your product submission. The submission cover sheet is also used for pre-submission requests, De Novo applications and other types of device submissions. During this presentation I will review each section of FDA Form 3514 and explain when each section applies and how to complete it.
What’s Included in the 510k Cover Letter Webinar?
- a recording of the webinar you can replay anytime
- my updated 510k Cover Letter template
- a copy of FDA Form 3514
- a template I created for a supplement to FDA Form 3514
- the native slide deck for this webinar
There are 22 slides in this presentation, and the presentation is 20 minutes in duration. This presentation is a recorded presentation, but please submit questions to me by email at email@example.com.
510k Cover Letter Webinar ($29)
In this 20 minute webinar you will learn how to prepare a 510k Cover Letter and complete FDA Form 3514–including identification of recognized standards. You will also receive copies of the templates for both documents–updated for 2020.
- Sterilization Shelf-Life Webinar – $49
- 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.