Hardware Podcasts

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

Global Medical Device Podcast · 2 Sept 2020 · 45m · Episode 162

What this episode covers

Mike Drues from Vascular Sciences explains the FDA's Safety and Performance Based 510(k) (SP 510(k)) pathway, noting it applies only to Class 2 or lower devices with well-established technologies like cutaneous electrodes and Foley catheters. He argues the pathway is politically motivated to compete with EU regulations and is currently too limited, suggesting industry should proactively define standards rather than waiting for FDA guidance. Drues proposes applying Product Development Protocol (PDP) logic to expand the program, urging companies to engage in pre-submission meetings to ensure testing completeness.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences, Green Light Guru, Greenlight Guru
Products
Foley catheter, cutaneous electrodes
Also
FDA

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