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 announced 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.

“The idea of just routinely going out to do an audit for a company doing quite well...is probably not the best utilization of the agency’s limited resources,” said Robin Newman, director at CDRH’s Office of Compliance. “It would be much better to go out and use those resources in areas where situations are not under control.”

The FDA also wants to get to the point where it isn’t industry’s “mortal enemy,” according to Newman. Industry should count on the FDA to be consistent just as much as the FDA should count on industry to meet requirements, she said, adding that is part of what the agency is trying to accomplish with this program.

By interacting with companies of different sizes using different manufacturing practices within their sites, the FDA will seek to address the process for identifying defects in devices that have or have not yet been distributed for “rapid containment and resolution of those issues,” explained CDRH Deputy Director for Regulatory Affairs Capt. Sean Boyd.

Participating companies will work in collaboration with the FDA, the Medical Device Innovation Consortium, and the CMMI Institute throughout the one-year program to identify best practices for quality manufacturing.

The pilot will launch in January 2018 and the agency hopes to have at least 30 sites involved. “We expect that firms will develop robust action plans that will be followed up on with clear timelines and deliverables to ensure that issues are addressed,” Boyd said. “When we discover instances where issues have not been communicated…we will look to revert back toward our traditional compliance and enforcement options as opposed to these interactive approaches.”