The pilot program led by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) aimed at manufacturing and product quality has gained momentum this year, with dozens of waived post-approval and risk-based inspections among participating firms.
The pilot program is collectively run by CDRH and the FDA-funded public-private partnership Medical Device Innovation Consortium (MDIC) and the CMMI Institute under CDRH’s 2014 Case for Quality (CfQ) initiative. It was launched
earlier this year to operationalize the third-party maturity appraisal model the CMMI Institute developed specifically for the medical device sector.
Pilot statistics shared at a Wednesday MDIC forum suggest the quality-based approach to regulatory oversight has proven to be effective in driving cultural change among participating manufacturing sites.
The pilot was set to run through 28 December 2018 but the current progress drove the decision for it to continue into 2019, CfQ program manager at CDRH, Cisco Vicenty, noted. “Participants have sailed over the compliance bar,” he said, noting that the transition away from the for cause approach is a learning process that will continue to evolve with feedback from industry, the CMMI Institute and MDIC, among others, over the course of the pilot.
In exchange for a commitment to organizational and product quality, 18 companies enrolled to participate in the CfQ pilot, and CDRH pledged to ease the burden associated with meeting certain regulatory requirements such as forgoing site inspections. New metrics show a total of 40 routine and four pre-approval inspections have been waived during the pilot’s first year.
The statistics also show 13 of the 40 sites enrolled manufacture both Class II and Class III devices, followed by devices of all classifications at seven sites, Vicenty, reported during the MDIC forum. Only four of the 28 appraisals completed so far were multi-site.
Agency review staff have also streamlined reviews of submissions for manufacturing changes or site changes, with 35 submissions completely reviewed in five days or less and an average review time of 2.8 days. Among these submissions, one was reviewed within 13 hours of receipt.
An employee of a participating firm that recently completed its second appraisal touted the results because the appraisal versus is less burdensome than a site inspection
Yet constraints associated with participation costs—largely driven by a long onboarding process—have reportedly
caused some smaller firms to disenroll, Cisco said during an MDIC forum earlier this year. The time from enrollment to an appraisal can be up to 110 days, according to the pilot statistics.
CDRH is looking at program scalability, regulatory modifications, adjusting the framework for multi-site appraisals and exploring low to noncompliant organizations, among other considerations, as it continues to develop the pilot heading into 2019. The center is also seeking input for a new program name and whether to create a new program charter this fiscal year.
Last month, Vicenty noted
during a forum at RAPS’ 2018 Convergence a second appraisal model to expand on the in-scope practices areas is in the works as well. The second appraisal model would include design, supplier management and device servicing to bridge the process with site inspections.