How to Prepare a 510(k) Submission for the FDA
Regulatory expert Robert Packard provided solid tips on how to prepare a 510(k) submission for the FDA.
He covered:
• How to select a predicate
• How to use the new FDA guidance and flow chart for determining substantial equivalence
• How to plan and manage your 510k project
• How to avoid “Refusal to Accept” (RTA)
• … and answered your live questions.
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