With plans to establish a full program next year, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) recently met its goal to complete at least 30 appraisals under the voluntary case for quality (CfQ) pilot program by year’s end.
CDRH had already completed a total of 35 appraisals across 18 device companies, as of earlier this month, in collaboration with the Medical Device Innovation Consortium (MDIC) and the CMMI Institute, CfQ program manager Cisco Vicenty said at a RAPS’ 2018 Convergence forum.
The pilot was announced last year and kicked off earlier this year. The CfQ initiative, launched in 2011, aims to shift the image among device makers of FDA being the “bad guy” who comes in for enforcement toward greater transparency, predictability, engagement and collaboration.
Device makers “should not be doing things that do not make sense just because the regulator is going to ask for it,” Vicenty argued. “That is something we need to shift and reset.” This is currently done by leveraging a maturity appraisal model developed by the CMMI Institute.
The CfQ pilot was also designed to provide certain benefits to participating companies based on organizational excellence. Potential benefits include achieving time and cost savings associated with streamlined approvals. Some participants have already reaped benefits such as achieving a problem-solving mindset to quality issues, while others have reportedly faced cost constraints.
A set of four new working groups will seek to fill in the gaps in the CfQ pilot, Vicenty noted. The working groups were created by the CfQ steering committee at MDIC—a public-private partnership charged with exploring ways for CDRH to implement its various new initiatives.
The groups’ work will be focused on redesigning processes around corrective and preventive actions, engaging the C-suite, quality as a career option and creating an industry safe place.
CDRH is also working to define a second appraisal process to include design, supplier management, and device servicing. The new appraisal process, which intends to bridge the gap between undergoing the appraisal process and manufacturing site inspections, may come as early as next year with the establishment of CfQ as an official program, according to Vicenty.
Participating company ZOLL brought the issue of the current lack of a connection between an appraisal and manufacturing site inspections to FDA’s attention earlier this year, regulatory affairs specialist Kurdea Lyon told Focus. The company argued that applying greater emphasis on quality throughout the entire medical device ecosystem can help ensure long term success.
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