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5 Ongoing US FDA Device Center Pilot Programs: A Listing

Executive Summary

Having trouble keeping track of the many pilot programs offered by US FDA's device center? Then this handy listing of ongoing pilots should help.

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Case For Quality Belly-Flop? FDA's PMA Critical-To-Quality Pilot Has Zero Enrollees After 10 Months

Device-makers have given a collective shrug to US FDA's Premarket Approval Critical-to-Quality (PMA CtQ) pilot program, a Case for Quality initiative that aims to identify "critical-to-quality" attributes for an array of products and ensure that quality is built into devices at their earliest stages. Since the pilot began in September 2017, no firms have enrolled. FDA's Bleta Vuniqi surmises that the empty pilot might be a victim of a glut of FDA pilot programs. Meanwhile, the agency has been talking internally about ways that the fledgling PMA CtQ pilot could be absorbed by FDA's burgeoning CMMI maturity model pilot.

Planned US Device-Center Reorg Will Be Organized Around Device Types

CDRH compliance official Sean Boyd described agency plans to group staff in device-specific offices that would handle products from pre-market review through inspections and enforcement. If approved, the reorganization would go forward in 2018.

Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot

In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?

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