9 Device-Makers Wanted For US FDA Pilot Program To Measure Quality System Maturity
US FDA is looking for nine medical device firms to enroll in its Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program, which will use third-party Capability Maturity Model Integration (CMMI) appraisers to evaluate a company's quality system maturity as a view into whether it is operating above a compliance baseline.
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Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites
The pursuit of quality can be a daunting task for device-makers. One wrong step can cause costly product recalls affecting patient health – among other troubles tied to poor quality products and processes. To help firms move toward a goal of best-in-industry quality, US FDA, through its Case for Quality initiative, has convened a pilot program to measure a manufacturer's capability and maturity to help put it on a path to continuous improvement. The pilot uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method, developed jointly by FDA, industry and CMMI Institute.
In a new "action plan," FDA is stitching together a plethora of ongoing and proposed initiatives to help spur product safety and quality efforts through increased regulatory authority and more incentives for device-makers.
If Congress approves a 26% higher 2019 funding request for US FDA's device center, a substantial chunk of those dollars would go to building a novel framework for regulating digital-health technologies, and to help FDA and device manufacturers respond better to cybersecurity vulnerabilities, among other program priorities, according to agency officials.