Depending on the level of quality and compliance, medical devices can impact patients’ lives for better or for worse. Fortunately, FDA recently announced plans to open up and expand participation for its Case for Quality Initiative.

Today’s guest is Mike Drues of Vascular Sciences. We discuss the benefits and incentives for compliant and noncompliant companies to participate in the Case for Quality program. Compliance doesn’t necessarily ensure quality.

Some of the highlights of the show include:

● Pilot Program Premise: Partnership between FDA, MDIC, and CMMI Institute to promote compliance and focus on true quality products and processes.

● Case for Quality is newer program with somewhat skewed participation from larger companies due to incentives favoring PMA Class III products.

● Case for Quality: Advantages for participating include being excused from routine FDA inspections when state of compliance was demonstrated previously.

● Making changes to positively impact PMA products involves challenging process to submit a supplement. Are regulatory requirements for changes necessary?

● Micromanage Case for Quality: Root cause for such regulations is to prevent shortcuts and oversee those that don’t know what or how to be in compliance.

● Why are some companies not in compliance? They should participate in the Case for Quality Initiative to learn what they need to do.