Hardware Podcasts

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

Global Medical Device Podcast · 12 Mar 2020 · 38m · Episode 136

What this episode covers

Mike Drues of Vascular Sciences explains the FDA's eSTAR (electronic Submission Template And Resource) pilot program, a PDF-based 510(k) template designed to streamline administrative reviews. He details the specific eligibility requirements, including the need for software and tissue contact, and critiques the program's lack of incentives for small companies compared to large ones. Drues argues that while eSTAR standardizes submission format, it does not reduce regulatory burden or scientific review time, comparing it to TurboTax for medical devices.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
FDA, Vascular Sciences, Greenlight Guru
Products
eSTAR, TurboTax
Also
510(k)

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