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Compliance In Focus
Posted by Natalie Jarmusik on Fri, Jun 19, 2015

Medical Device Regulations

You may be familiar with IMARC Research’s History of Clinical Research (HCR). We recently released an Medical_Device_Ammendment_ActeBook about it that briefly describes all of the images that currently make up the timeline. If you have visited our office, you may have also been given a guided tour of one of our most renowned resources. Due to the overwhelmingly positive feedback we have received, we will be highlighting each time point with a series of blogs that we plan to release over the course of the 2014-2015 calendar year.

Until 1974, the medical device realm of clinical research had been operating under device regulations presented in the Food, Drug, and Cosmetic Act of 1938 – legislation that, at the time of its enactment, provided comprehensive guidance for industry professionals. More than thirty years later, however, the medical device industry had achieved advancements and growth that required increased legitimacy in regards to its governance and control, and therefore updated regulations to oversee production and implementation of these new devices. In response to this need for updated regulations, the FDA created the Bureau of Medical Devices and Diagnostic Products. By creating this new bureau, the FDA hoped to more easily differentiate between legitimate and illegitimate medical devices and thereby improve the safety and reliability of the medical device field.

Between the years of 1974 and 1976, the FDA worked with Congress as well as industry experts on many drafts and revisions to the Food, Drug, and Cosmetic Act, which ultimately resulted in an amendment. The amendment was signed into law by President Ford on May 28, 1976, and it outlined a need for the classification of devices in addition to new controls appropriate for each respective device class. With such an amendment, devices such as pacemakers or surgical implants (i.e. devices that would be classified as critically important) would now need to be proven safe and effective prior to receiving any marketing for consumers.

The FDA’s new legislation operated almost fifteen years prior to receiving advancement. In 1990, the Safe Medical Devices Act was put into effect, an act that required nursing homes, hospitals, and any other facility using medical devices to report to the FDA any incidents suggesting that a medical device may have contributed to the death, serious illness, or serious injury of a patient. Additionally, the Safe Medical Device Act produced a requirement for all manufactures to conduct post-market studies on permanently implanted devices whose failure could cause serious injury or death to a subject, as well as to establish methods for tracing and locating patients based on the devices they had received. Finally, the act also authorized the FDA to order device recalls if they suspected a product may be mis-performing.

Over the past 75 years, the medical device field has experienced numerous improvements targeted towards ensuring patient safety.  Do you feel the medical device industry has room for continuous improvement? Where do you see legislation heading for new devices?  Please let us know your thoughts below!

Image Credit: Nicolette Capuano

The History of Clinical Research

Topics: History of Clinical Research Timeline, FDA, Medical Device Industry, President Gerold Ford


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