AAMI News December 2019

CDRH Quality Pilot Expands to Noncompliant Manufacturers

MDICThe Food and Drug Administration (FDA) has awarded the nonprofit Medical Device Innovation Consortium (MDIC) $2.8 million to expand their Case for Quality Voluntary Improvement Program (CfQ VIP) pilot to include medical device manufacturers that are not compliant with the agency’s quality system regulations.

The agency hopes that inclusion in this new version of the CfQ VIP pilot, previously called the Center for Devices and Radiological Health (CDRH) Voluntary Medical Device Manufacturing and Product Quality Program, will help put noncompliant manufacturers on a path to returning to compliance.

“The expansion of this program will enable us to further collaborate with MDIC to enhance the success of CfQ VIP while promoting high-quality devices and increasing patient safety,” said Jeff Shuren, director of the FDA’s CDRH, in a statement.

The pilot program provides companies with a quality maturity appraisal framework defined by the Capability Maturity Model Integration Institute for assessing their ability to produce high-quality products and use that information for continuous improvement. The noncompliant CfQ VIP program will use the original program’s quality maturity appraisal and product safety metrics and will add a regulatory compliance perspective using the international quality management system standard ANSI/AAMI/ISO 13485:2016.

The participants would, in turn, be able to use results from their quality maturity appraisal in their remediation documentation for returning to FDA compliance. However, noncompliant participants are not eligible to receive the same regulatory incentives that are offered to FDA-compliant CfQ VIP participants, such as independently monitored performance and withdrawal from routine FDA inspections.

The FDA partnered with industry to create MDIC in 2012, with the goal of advancing medical device regulatory science by creating new tools to evaluate product safety, quality, and effectiveness. MDIC launched the CfQ VIP pilot in 2015 for medical device manufacturers that are compliant with FDA quality system regulations.

A portion of the $2.8 million will also go towards studying and identifying barriers to best-practice adoption in nonmedical device industries and cybersecurity threat modeling for the total life cycle of medical devices. MDIC plans to produce a bootcamp on threat modeling for medical device stakeholders, as well as a playbook on threat modeling for manufacturers.