ARTICLE SUMMARY:
A draft guidance outlines FDA’s plans to roll out the previously piloted Voluntary Improvement Program, in which companies can undergo appraisals for organizational “maturity” and benefit from quicker manufacturing reviews from the agency.
A nascent FDA program designed to incentivize companies to invest in organizational quality beyond base legal requirements and support advanced manufacturing got a boost with a new draft guidance from the agency.
The Voluntary Improvement Program (VIP) has been in the works, in collaboration with the Medical Device Innovation Consortium, as a pilot program for several years. It is one of the main outputs of CDRH’s 2011-launched Case for Quality initiative intended to shift industry’s mindset from a focus on legal compliance to device quality. The May 6 draft guidance, “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program,” is a key step toward expanding VIP as a permanent program available to the entire device industry.
