REGULATORY WATCHCAT De Novo Post-Mortem 4 – Design Controls

Watchcat

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What the Regulatory Watchcat said:

CDRH has been talking a lot about “modernizing” lately, but it cannot seem to modernize itself. Most of the contents of this section are taken directly from § 814.20, much of which is vintage 1986. The Design Controls regulations were passed in 1996, 22 years ago and counting. It is way, way past time for ODE to start acting like it ever even read them, much less understood them, much less lifted a finger to implement them. Step 0 would be to tailor the format and content of all premarket submissions to be consistent with design controls. All premarket applications should include the design and development plan, design input, output, reviews, verification, validation, transfer, and every single design change since V&V was started.

My full comment, CDRH’s response, and my comments on its response, are attached.
 

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