By Kellen Hills, Contributing Writer
Today’s market realities have reshaped the role of regulatory affairs within the medical device development process. But are companies keeping pace?
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 are now 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.
See more at: http://www.mpo-mag.com/issues/2014-11-01/view_features/the-new-role-of-regulatory-affairs-in-medical-device-manufacturing/#sthash.K2E7lDcS.dpuf
