The History of the FDA

by | Aug 19, 2021 | FDA

One of the oldest protection agencies in the US federal government, the Food and Drug Administration’s modern regulatory functions began with the pass of the 1906 Pure Food and Drugs Act, a law that was a quarter-century in the making. Before then, the federal government utilized chemical analysis to monitor the safety of products, specifically agricultural products throughout the US; this was a responsibility that was inherited by the Department of Agriculture in 1863 and later by the current FDA. Since its beginning in the early 19th century, the FDA has authored and passed economic, political, social, and legal amendments and bills in the US. Examining the history of the FDA and these changes demonstrate the evolving role that the FDA has played in promoting general safety and health of the public, as well as illustrating the history of how the US evaluates current regulatory affairs and challenges.

Get the Culture and Medical Device Quality Whitepaper

Fill out the form below, and the webinar will get sent directly to your inbox.
Abby McVay

Abby McVay

Research Analyst- Ms. McVay is EMMA International’s Research Analyst. She has experience in technical writing and clinical trials in many life science industries. She has experience with many different elements of quality and regulatory compliance. Ms. McVay holds a Bachelor of Science in Psychology from Manchester University as well as a Master of Science in Industrial and Organizational Psychology from Angelo State University.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

Ready to learn more about working with us?

Pin It on Pinterest

Share This