Overview: Product Safety

The medical technology industry is committed to patient safety. FDA guidelines are the standard to be met, but our goals are set higher: moving people forward with the best science and technology. We are dedicated to advancing medical technology to improve patient care and helping people live longer, healthier, more productive lives.

A Strong FDA Protects Patients

The medical technology industry recognizes the importance and value of a strong and independent FDA, whose guidelines set the global "gold standard" for product safety.

FDA's rigorous requirements cover the entire life of a new medical technology — from early design and development phases to years after a technology is being used by patients and doctors.

Patient Safety is Job One

Before reaching the market, medical technologies are thoroughly and rigorously evaluated for safety.

Each year, FDA subjects thousands of medical technologies to exhaustive, science-based reviews. We work with the FDA to make sure they have the information needed to make their decisions.

Not every review process is the same. Individual medical technologies are as unique and complex as the ways they improve patients' lives. Recognizing that diversity, FDA pre-market reviews are tailored to be appropriate for the individual device.

Patient Safety is Ongoing

The safety process doesn't stop once our technologies are approved.

Reporting requirements allow manufacturers and the FDA to detect and identify unanticipated problems quickly, and address them effectively.

In addition, feedback from physicians and patients allows us to improve on current technologies and develop the next generation of innovation.

Patients Should Understand Benefits and Risks

Advanced medical technologies have enriched the lives of millions of patients worldwide, and our industry takes enormous precautions to protect those patients. But as in every industry, unanticipated problems can, and will, occur.

Working with the FDA, our industry has policies and procedures in place to address issues as quickly and effectively as humanly possible.

Our industry takes a pro-active approach to safety, which is why 99 percent of recalls are voluntary and initiated by the company.