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Browse FDA-TRACK Program Areas or Center for Devices and Radiological Health Index

Strengthen Product and Manufacturing Quality within the Medical Device Ecosystem

Description: CDRH 2016-2017 Strategic Priorty: Promote a Culture of Quality and Organizational Excellence

Definition: Goal: Strengthen Product and Manufacturing Quality within the Medical Device Ecosystem

Briefing Status: Completed

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
A. By September 30, 2016, develop metrics, successful industry practices, standards, and tools that manufacturers can use to evaluate product and manufacturing quality beyond compliance with regulatory requirements. 9/30/2016
 Completed 9/30/2016-Partnered with MDIC to develop metrics and best practices to assess quality system performance, and analytical tools to assess device quality by hospital value analysis committees.
B. By December 31, 2016, pilot voluntary use of product and manufacturing quality metrics and evaluation tools. 12/31/2016
 Completed 12/31/2016-Partnered with MDIC and Capability Maturity Model Integration (CMMI) Institute on a proof-of-concept and pilot with three device manufacturers, to evaluate use of the CMMI appraisal process as a foundation for a future third party program.
C. By December 31, 2017, propose a voluntary program to recognize independent evaluation of product and manufacturing quality. 12/31/2017
 Completed 12/31/2017-Announced in 2017, the voluntary Case for Quality (CfQ) Pilot Program. The pilot intends to explore the effectiveness of a quality maturity appraisal, the use of objective metrics, optimization of resources, and impact on quality culture and manufacturing quality.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.

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