New Voluntary Medical Device Manufacturing and Product Quality Pilot Program

The FDA invites registered firms to consider participating in the Voluntary Medical Device Manufacturing and Product Quality Pilot Program, an effort led by the Center for Devices and Radiological Health (CDRH). Top-quality medical devices help the FDA better protect and promote public health. The FDA believes that proactive engagement with medical device manufacturers and a focused inspectional approach will promote quality in device design and manufacturing. Beginning on January 2, 2018, the FDA will select up to nine applicants for the pilot program. The FDA intends to work collaboratively with the applicants to implement a pilot program that recognizes an independent assessment of design, manufacturing and product quality among medical device manufacturers. Using independent performance evaluations, the voluntary pilot program seeks to identify quality-focused measures taken by manufacturers who have demonstrated a good compliance history as they design and manufacture their medical devices. In this pilot program, third-party teams certified by the Capability Maturity Model Integration (CMMI) Institute will conduct quality system maturity appraisals using a maturity appraisal model developed by the CMMI Institute. The goal of these appraisals is to drive continuous improvement and organizational excellence among participating medical device manufacturing sites. Each of the participants is responsible for covering their own appraisals’ costs. To learn more about whether your firm may be eligible to participate in the pilot program, see the Participation section of the Federal Register Notice. Other recently-announced FDA pilot projects built around a goal to streamline the premarket approval process include: Premarket Approval Application Critical to Quality Pilot Program Digital Health Software Precertification (PreCert) Program Medical Device Single Audit Program (MDSAP) Food and Drug Administration Center for Devices and Radiological Health