FDA Proposes Framework for Quality Manufacturing Pilot Program

The FDA proposed a framework for a voluntary pilot program aimed at using industry assessments of manufacturing quality to reduce the agency’s oversight actions.

The Voluntary Medical Device Manufacturing and Quality program will be based on a company’s “maturity model appraisal as opposed to a compliance model,” said CDRH Director Jeffrey Shuren during an Oct. 10 FDA workshop on the program. The maturity framework is used for assessing a manufacturing facility’s capability and performance level.

The voluntary program is one of several initiatives the FDA has recently launched as it continues to reevaluate how its resources are allocated while it increasingly comes under pressure to reduce regulatory burdens on industry, such as site disruptions caused by audits.