Hardware Podcasts

7 Common 510(k) Mistakes and How to Avoid Them

Global Medical Device Podcast · 29 Sept 2022 · 55m · Episode 282

What this episode covers

Mike Drues, president of Vascular Sciences, joins host Jon Speer to discuss seven common mistakes in FDA 510(k) submissions based on Speer's earlier article. They cover critical errors such as inconsistent documentation, failure to use the Refuse to Accept (RTA) checklist, and insufficient testing data. The conversation also addresses the nuances of shelf-life claims for software and the strict requirements for demonstrating substantial equivalence to a predicate device.

Most relevant to

established companies

Topics

Mentioned

Companies
Green Light Guru, Vascular Sciences
Also
FDA, ISO 14971

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