Time capsule: Anniversary of Medical Device Amendments brings back memories

By now, our industry is used to changes, used to regulations, used to aligning innovation with proven patient safety. Forty years ago, one of the biggest changes in medical device development and manufacturing took place. Recently, the U.S. Food and Drug Administration (FDA) held a Celebration of the 40th Anniversary of the Medical Device Amendments (MDA). Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH), opened his remarks at the event by taking us back to the time in 1976 when President Gerald Ford signed the MDA into law, giving FDA additional authority in regulating medical devices. In his opening statements, Dr. Shuren asks the audience the following question, “Anyone thought about where they were or what they were doing in 1976?”

I answered that question with “I know where I was!”

It was a beautiful spring for me in Indiana as a new employee of Cook Incorporated. I was just barely beginning to get familiar with this new company that I had just started to work for in March of 1976. I was stationed just inside the entryway at the front desk of the Cook office at 925 South Curry Pike. I had a multi-line telephone on my desk and directed incoming calls for the key executives, who at that time were Mr. Cook, Tom Osborne, Phyllis McCullough, Miles Kanne, Ross Jennings, Brian Bates, and Phil Hathaway. In addition to answering the telephone, greeting incoming visitors and helping to organize schedules, meetings and events, I also provided clerical services for Miles and Ross at a time when there was no e-mail, electronic copies, or personal computers! My job at the front desk was short lived because of growth in the Customer Service area, which was just around the corner from my desk. The phones rang constantly over there! At that time, our U.S. sales team was divided into six regions (Staffan Grigholm/Western, Wayne Vaughan/Southern, Tom Bowen/Mid-Atlantic, Gene DeVane, MidWestern, Frank Longson/Mountain and Henry Kahn/Northeast) to help customers align with staff in the office. Taking orders for our products was primarily done through conversations on the telephone, and the six of us in Customer Service were on the telephone almost continuously every day! Our products were in great demand and being a Customer Service Representative required extensive product knowledge since customers often didn’t often know the full extent of what we had available or what we could make as a special order.

When the Medical Device Amendments (MDA) were signed into law on May 28, 1976, it drastically changed things in the industry, providing new criteria for medical device manufacturers to meet with respect to premarket and registration activities. Our executive team immediately began communicating with the Bureau of Medical Devices (the old name of CDRH) to comply with the new requirements of the MDA, which included among other things that we register our establishment. We also had to list our devices that were in commercial distribution before enactment of the MDA (these were “grandfathered” from the premarket review requirements). FDA also was required to classify all medical devices according to a risk classification system of I, II or III (lowest to highest risk). Requirements for FDA clearances of premarket 510(k) submissions and approvals for premarket approval applications for new products as well as other reporting requirements were also added requirements of the MDA.

The MDA wasn’t the only change that impacted our work around that time. In 1978, the requirements for Good Manufacturing Practices became effective. The GMP requirements are now referred to as the Quality System Regulations (QSR). These regulations, along with the International Standard (ISO) 13485 and various other governments’  laws, establish requirements for our Quality System.

For 40 years, we have continued our journey to work with the staff at FDA and all our governing regulatory agencies in our combined efforts to help bring safe, effective and life-improving technologies to patients around the globe.

You can read Dr. Shuren’s remarks celebrating the 40th anniversary of the MDA. We hope you will continue to enjoy the journey we are all on together!