When a 510(k) clearance number has been assigned by FDA, it does not expire, but medical device and IVD (In Vitro Diagnostics) companies must remain in compliance with FDA regulations to continue selling their products in the USA. Most Class II medical devices and a small number of Class I and Class III medical devices must undergo the FDA 510k process in order to obtain FDA approval to be sold in the US market. You can also follow him on Google+, LinkedIn, or Twitter. He can be reached via phone at 802.281.4381 or by email. The most favorite part of his job is training others. 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. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies.
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His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. Rob was a senior manager at several medical device companies-including the President/CEO of a laparoscopic imaging company.
He is a graduate of UConn in Chemical Engineering.
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage. This presentation is a recorded presentation, but p lease submit questions to me by email at 510k Cover Letter Webinar ($29)Īdditional Resources for 510k submissions There are 22 slides in this presentation, and the presentation is 20 minutes in duration. a template I created for a supplement to FDA Form 3514.a recording of the webinar you can replay anytime.What’s Included in the 510k Cover Letter Webinar?
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During this presentation, I will review each section of FDA Form 3514 and explain when each section applies and how to complete it. The submission cover sheet is also used for pre-submission requests, De Novo applications, and other types of device submissions. The submission cover sheet includes details that are used to create a database entry for you, your company, and your product submission. In addition to the 510k Cover Letter, there is also a submission cover sheet that must be prepared (i.e., FDA Form 3514). Does the submission include clinical information?.There are also specific questions that the reviewer needs to be answered about your product in order to identify specific specialists that may need to be involved, such as: The 510k Cover Letter also includes a statement that your submission includes a paper copy and an eCopy.
Why you should register for the 510k Cover Letter Webinar?Ī 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.
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