Why do we need fda approval

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Last updated: April 8, 2026

Quick Answer: FDA approval is required to ensure that drugs, medical devices, and biologics are safe and effective for public use, based on rigorous scientific evaluation. The FDA's authority stems from the 1906 Pure Food and Drugs Act and was significantly expanded by the 1938 Federal Food, Drug, and Cosmetic Act after the sulfanilamide elixir tragedy killed over 100 people. In 2022, the FDA approved 37 novel drugs and reviewed thousands of medical devices, with approval processes typically taking 6-12 months for devices and up to 10 years for drugs. Without this oversight, unproven or dangerous products could reach consumers, as seen in historical incidents like the thalidomide crisis of the 1960s.

Key Facts

The FDA was established in 1906 with the Pure Food and Drugs Act, initially focusing on food safety
In 1938, the Federal Food, Drug, and Cosmetic Act mandated pre-market safety approval for drugs after 107 deaths from sulfanilamide
The 1962 Kefauver-Harris Amendments required proof of efficacy for drugs, prompted by thalidomide birth defects
In 2022, the FDA's Center for Drug Evaluation and Research approved 37 novel drugs and reviewed over 4,000 medical device applications
FDA approval processes average 6-12 months for medical devices via 510(k) clearance and up to 10 years for new drugs through clinical trials

Overview

The Food and Drug Administration (FDA) is the United States federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and radiation-emitting products. Established in 1906 with the passage of the Pure Food and Drugs Act, the FDA's initial focus was preventing adulterated foods and misbranded drugs. A pivotal moment came in 1938 with the Federal Food, Drug, and Cosmetic Act, which mandated pre-market safety approval for new drugs after the sulfanilamide elixir tragedy killed 107 people, mostly children. This was followed by the 1962 Kefauver-Harris Amendments requiring proof of efficacy, prompted by the thalidomide crisis that caused severe birth defects worldwide. Today, the FDA regulates over $2.8 trillion worth of consumer goods annually, representing approximately 20% of all consumer spending in the U.S.

How It Works

The FDA approval process involves multiple stages of scientific evaluation depending on the product type. For new drugs, developers must submit an Investigational New Drug (IND) application followed by three phases of clinical trials involving thousands of participants over 6-10 years, culminating in a New Drug Application (NDA) review. Medical devices follow different pathways: Class I devices (low risk) require general controls, Class II devices (moderate risk) typically need 510(k) clearance demonstrating substantial equivalence to existing devices, and Class III devices (high risk) require Premarket Approval (PMA) with clinical data. The FDA employs over 18,000 scientists, physicians, and other professionals who review approximately 20,000 drug and device applications annually. Decisions are based on risk-benefit analysis, with accelerated pathways available for breakthrough therapies addressing unmet medical needs.

Why It Matters

FDA approval matters because it provides evidence-based assurance that medical products are safe and effective before reaching patients. This regulatory framework has prevented countless public health disasters while enabling medical innovation, with FDA-approved products contributing to increased U.S. life expectancy from 47 years in 1900 to 79 years today. The system balances access to new treatments with safety considerations, particularly important for vulnerable populations. Globally, FDA standards influence international regulations, with many countries referencing FDA decisions in their own approval processes. Without this oversight, consumers would face unpredictable risks from untested products, as demonstrated by historical tragedies that shaped the current system.