Case for Quality Pilot Activities
Voluntary Medical Device Manufacturing and Product Quality Pilot Program
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 CMMI. The goal of these appraisals is to drive continuous improvement and organizational excellence among participating medical device manufacturing sites. Enrolled participants commit to engage early with CDRH and are required to submit baseline metrics before and during the appraisal to monitor their progress. Although this pilot program is open to nine participants, the FDA will look for ways to engage in discussions with firms that requested to participate but were not officially selected for participation. Participants are responsible for covering their own appraisals’ costs.
Through this program, the FDA intends to forego conducting surveillance and preapproval inspections for participating manufacturing sites, reducing the burden and disruption such inspections may cause and allowing participants to shift resources to innovation and improvement efforts.
Interested manufacturers can refer to the FR notice about this pilot program to find more information, including participation criteria and instructions on how to request to participate.
Premarket Approval (PMA) Critical-to-Quality Pilot Program
This pilot allows PMA device manufacturers that meet the participation criteria to engage with the FDA early in the review process of new PMA applications. This program does not represent a new requirement. However, the FDA believes that proactive engagement with PMA applicants on development of critical-to-quality characteristics and controls for their device and a focused inspectional approach will promote quality in device design and manufacturing. The goal of this voluntary pilot program is to streamline the premarket approval process while assuring that a firm's quality system includes controls for features and characteristics considered critical to the safety and effectiveness of the device. The program is open to nine participants and does not include an additional cost to the PMA applicant to participate.
Through this program, the FDA intends to forego conducting a preapproval inspection, which it would usually conduct, and instead conduct a post-approval inspection. Such post-approval inspection would focus on the design, manufacturing, and quality assurance practices identified by the applicant in its PMA.
Interested manufacturers can refer to the Federal Register (FR) notice about this pilot program to find more information, including participation criteria and instructions on how to request to participate.
Other CDRH Programs Focused on Quality
Voluntary Compliance Improvement Pilot Program
This pilot program is currently inactive and the FDA is not accepting requests to participate until further notice. Four firms participated in this program from May 2014 to December 2016, during which firms voluntarily self-identified and corrected possible regulatory violations instead of undergoing FDA inspection. Regulatory violations may include quality system violations and other problems, such as failure to satisfy device clearance or approval requirements or adverse event reporting requirements.