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By: Scott Whitaker, President and CEO, AdvaMed
March 15, 2018

For the MedTech Industry, Safety is Job #1

Doctors take an oath to “First, do no harm.” Medical technology companies make the same pledge. In fact, I'd say the industry’s commitment to helping patients live longer, healthier, more productive lives is matched only by its dedication to quality and safety.

As we commemorate Patient Safety Awareness Week, I think it's important for policymakers and the general public to understand just how much goes into making sure the medical devices and diagnostics physicians use every day to improve patient care are safe and effective.

First of all, the medical technology industry is highly regulated. In the U.S., that job falls to the Food and Drug Administration, (FDA), which sets rigorous requirements that cover the entire life of a new medical technology – from the early design and development phases to years after a device is being used by patients and doctors.

Industry recognizes the importance and value of a strong and independent FDA, whose guidelines set the global “gold standard” for product safety. We are both committed to providing patients and physicians with the safest and most effective medical technologies in support of our mutual goal of improving patient care.

Long before any medical device or diagnostic reaches the market, medical technologies are thoroughly and rigorously evaluated for safety. Each year, FDA subjects thousands of medical technologies to exhaustive, science-based reviews. Medical technology companies work with the agency to make sure they have the information needed to make their decisions.

Not every device review is the same. Individual medical technologies are as unique and complex as the ways they improve patients’ lives. Recognizing that diversity, FDA premarket reviews are geared so that the level of scrutiny and evidence required to show safety and effectiveness match the individual device.

  • The highest-risk devices require premarket approval applications (PMAs) and must be backed by extensive clinical and preclinical data that takes many years and millions of dollars to gather.
  • Many new tests and treatments pose much lower levels of potential risk and require less extensive types of data. These devices require so-called 510(k) premarket submissions.
  •  The simplest, lowest-risk products – like tongue depressors and thermometers – are exempt from premarket review.

FDA's rigorous premarket reviews are complemented by various requirements that continue to safeguard consumers after a medical technology is placed on the market.

  • Comprehensive "quality system" requirements ensure that companies' manufacturing processes consistently yield high-quality medical technologies.
  • Recall procedures established by FDA and manufacturers ensure that, if a problem arises, it is addressed as quickly and effectively as possible.
  • Mandatory adverse event reporting requirements provide a mechanism for FDA and manufacturers to detect and correct problems in a timely manner.
  • Postmarket surveillance and tracking requirements for certain higher-risk devices help ensure that rare, unanticipated problems are identified and addressed efficiently.

This comprehensive, risk-based approach to regulation helps ensure patients and physicians have timely access to safe and effective medical technologies. At the same time, it is flexible enough to accommodate for the great diversity in medical devices and allow for continued innovation.

Of course, every process can be improved, and we welcome any suggestions that would positively impact patient safety and access. But the bottom line is that the current regulatory scheme has served the American public well for decades, and we should all be proud of its track record on quality and safety.