Historically, interactions between industry and the FDA have been described as complex, challenging and even adversarial. Many a time, our firm has been asked to serve as an “anonymizer” for a medical device company that had a question for the FDA, but was concerned about interacting with the agency directly.
Would interactions be different if meetings between the agency and industry
stakeholders started with a hug? They did at the most recent Case for Quality Forum where industry and the FDA literally embraced, stating that providing medical products of the highest quality is their main focus.
The Case for Quality (CfQ) Forum consistently provides an open venue to discuss and exchange ideas on improving medical device product quality. The Case for Quality program was created to facilitate ongoing dialogue that will ultimately benefit patients, providers and the medical technology community. The initiative brings together industry stakeholders – including the U.S. Food and Drug Administration, medical device manufacturers, payers, providers, industry advisors and patient advocates. Continue reading