FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

CDRH’s Case for Quality Program Continues to Evolve

April 12, 2018

CDRH’s Case for Quality program manager highlighted changes on the horizon at the FDAnews 15th Annual Medical Device Quality Congress.

“We want to expand the appraisal focus from manufacturing to design. Design allows us to actually implement the same kind of rapid changes into the 510(k) space,” said CDRH’s Cisco Vicente.

The program will focus on simplification over the next couple of years to “incorporate the most concepts” moving forward, he said.

The agency plans to streamline non-product computer validation systems to encourage risk-based approaches to validation, he said, noting that implementing automated data analysis and manufacturing technologies can create delays due to the perceived regulatory burden and outdated auditing procedures.

CDRH also launched a pilot program in January, the Capability Maturity Model Integration (CMMI), which focuses on assessing and appraising medical device facilities as opposed to inspecting and auditing.

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