FDA’s Center for Devices and Radiological Health (CDRH) expects to fully implement its “Voluntary Manufacturing and Product Quality” program in 2020, following a positive experience during the pilot phase of this highly collaborative alternative to traditional agency inspections.
The voluntary improvement program is the outgrowth of the center’s “Case for Quality” (CfQ) initiative, which was launched in 2011. CDRH describes its CfQ effort as intended “to elevate the focus of all medical device stakeholders from baseline regulatory compliance to sustained, predictive practices that advance medical device quality and safety.”
In 2014, CDRH joined forces with the Medical Device Innovation Consortium (MDIC) to bring stakeholders across the medical device ecosystem together to collaborate on furthering the Case for Quality vision. MDIC is a public/private partnership of which FDA and other government organizations, industry, and additional stakeholders such as payers, providers, and patients are members.
A study report was released by MDIC in mid-2015. The report identified Capability Maturity Model Integration (CMMI) – a methodology used to assess and improve performance of critical activities across industries – as the best suited for the intended application.
Working through MDIC and the CMMI Institute, a third-party appraisal program was developed tailored to the medical device arena that assesses the relative maturity level of a company’s quality management systems, with a goal of driving continuous improvement and achieving organizational excellence.
A pilot on the appraisal program was launched by FDA in January 2018, which focused on device manufacturing and the associated support functions. It enabled the agency to evaluate the adapted review approaches on manufacturing submissions required for Pre-Market Approval (PMA) devices.
Device Pilot Report has High Pharma Relevance
An informative assessment of the Case for Quality voluntary improvement pilot experience was released by FDA in late September.
A review of the report reveals the high relevance of the new CDRH process and learnings to the collaborative initiatives underway on the CDER and CBER side that are directed at evolving the review/inspection paradigm to better foster a continuous improvement culture in drug and biologics manufacturing and better assure product availability (see IPQ December 12, 2019).