Feeling a little lost as you start to compile your first k submission? There is all this information out there to try and help you, but it can be overwhelming trying to sift through. The Ultimate Guide to k Submissions aims to put the requirements in easy-to-understand terms and includes some helpful, actionable and practical tips you can begin to implement immediately. The goal of this guide is to provide you step-by-step guidance through each part of the FDA k submission process and help improve your time to market.
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A k Cover Letter needs to include the administrative information that is needed to properly identify you, your company, the k submission type, applicable regulations, product classification, the review panel, the device product code and any previous submissions related to this k submission.
The k 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:.
In addition to the k Cover Letter there is also a submission cover sheet that must be prepare i. 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 and explain when each section applies and how to complete it.
There are 22 slides in this presentation, and the presentation is 20 minutes in duration. In this 20 minute webinar you will learn how to prepare a k Cover Letter and complete FDA Form —including identification of recognized standards. You will also receive copies of the templates for both documents. He is a graduate of UConn in Chemical Engineering.
From , he was a lead auditor and instructor for one of the largest Notified Bodies. The most favorite part of his job is training others. He can be reached via phone 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? Your cart is empty.
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U.S. Food and Drug Administration