The 510(k) Submission: Requirements, Contents, and Options 

This Video will show an understanding of how to get a device requiring a 510(k) submission to market quickly.
Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This video will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This video will show the submission process and the contents required by the FDA for a successful submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. Also described will be the type of activities a company can pursue while waiting for submission clearance.
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Organization: NetZealous BDA GlobalCompliancePanel
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Email: support@globalcompliancepanel.com
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