USA – FDA moves forward with Voluntary Improvement Program to bolster medical device quality

The US Food and Drug Administration has issued new draft guidance to establish a full-blown voluntary program for improving quality-related processes in medical device manufacturing following promising results of a pilot program.

The FDA guidance stems from a pilot undertaken by the agency along with the Medical Device Innovation Consortium (MDIC) in 2018. That preliminary effort was called the Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program, or CfQ Pilot Program