FDA Details New Manufacturing Quality Pilot Program

Regulatory NewsRegulatory News | 15 January 2018 |  By 

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) last month released details on its upcoming voluntary medical device manufacturing and product quality pilot program as part of its Case for Quality (CfQ) initiative.

"CDRH envisions a future state where the medical device ecosystem is inherently focused on device features and manufacturing practices that have the greatest impact on product quality and patient safety," FDA writes.

FDA first presented its plans for the initiative at a public workshop in October 2017.

Pilot Program

The pilot program, which features a capability maturity model integration (CMMI) system adapted to suit the needs of the device industry, will focus on appraising device makers' current manufacturing process performance based on "objective metrics, optimization of resources and impact on quality culture."

The appraisal model was developed in collaboration with the Medical Device Innovation Consortium (MDIC) and has been implemented in other manufacturing sectors, such as automotive, aerospace and defense.

FDA says the appraisals, which will be carried out by the CMMI Institute, will help to identify gaps that manufacturers can address to drive continuous process improvement that could eventually lead to safer and higher quality devices on the market while reducing the regulatory burden on manufacturers.

Participating device makers will receive the results of their appraisal from the CMMI Institute, and a summary report of the appraisal will be provided to FDA for each manufacturer.

"Data collected through the appraisal and pilot will help inform FDA on how to modify its requirements around surveillance and preapproval inspections, as well as the content of premarket manufacturing submissions in order to better allocate resources that could reduce the regulatory burden to appraised firms," FDA says.

The pilot program will be limited to nine device makers "who provide a holistic representation of the medical device industry." Each company will undergo an appraisal and will be exempt from routine FDA surveillance inspections during the pilot, though FDA says it will still conduct any necessary "for cause" inspections.

FDA also says it will look for ways to engage with device makers that are interested in participating in the pilot but are not officially selected to participate.

The agency began accepting submissions to participate in the pilot program through the MDIC website on 2 January 2018, and says the program will run until 28 December 2018.

Federal Register, FDA, Public Workshop


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