Kellen Hills

Call it a new paradigm. Call it a sea change. Or, if you prefer, call it downright frustrating. Whatever label you give to today’s medical device environment, the current and future reality is that the regulatory elements of medical technology now are just as important as how it’s designed, manufactured and marketed.

How times have changed. Most medical device veterans (those with 30 years or more experience in the industry), will remember a time when registering a device was a much simpler, straightforward process. Prior to 1976, if a medical device developer wanted to get a product to market, it could be done without any government oversight.

However, as biocompatibility issues and health scares rose, pressure mounted against the United States government to institute medical device-specific rules and regulations. On May 28, 1976, the Food, Drug, and Cosmetic Act (FDCA) was amended to include regulation for medical devices, and required all medical devices be systematized into one of three classes, with Class I devices being the lowest risk (e.g., elastic bandages), Class III devices posing the greatest risk (e.g., an artificial heart), and Class II devices falling somewhere in between (e.g., infusion pumps).

In addition, Section 510(k) of the FDCA required device manufacturers to notify the U.S. Food and Drug Administration (FDA) of their intent to market a medical device. Up until 2009, these 510(k) submissions were relatively uncomplicated—certainly when compared to today’s 510(k) requirement—which is why for more than two decades, very few medical device companies had a dedicated regulatory affairs (RA) group. And if they did, RA usually only had limited involvement with product development, marketing and manufacturing.

In 2012, RA’s role changed almost overnight with the passing of the Food and Drug Administration Safety and Innovation Act and the Medical Device User Fee Amendments of 2012, commonly called MDUFA III (the third iteration of the FDA’s user fee program). These pieces of legislation completely altered the regulatory landscape for medical device manufacturers (both OEM and contractor/suppliers). In addition to affecting how the FDA scrutinizes medical device manufacturers, the new rules also transformed the relationship between the regulatory affairs team and every other department within a medical device organization.

Going forward, the only efficient, cost-effective, and compliant way for U.S. medical device companies to get their products to market in the United States and abroad is to involve regulatory affairs in every aspect of a medical device’s life cycle—from concept through post-market surveillance. By cultivating a collaborative relationship between regulatory affairs and all other departments within the organization, medical device companies will be better able to protect themselves, their resources, their customers and ultimately the patients who benefit from the device.

Taking a 30,000-foot perspective, here’s how RA can offer valuable support and insight at each stage of a medical device’s life cycle: