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When to Submit a 510(k) for a Change to an Existing Device

Uploaded by compliance4All
Overview: This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) Why should you Attend: This presentation uses the latest FDA thinking and guidance documents to assist the manufacturers in enhancing the predictability, consistency, and transparency of the "when to submit" decision-making process by providing a least burdensome approach, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision.

Venue Details

  • Online Event

    161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA, Fremont Central OH

    800-447-9407

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