What is the U.S. Food and Drug Administration (FDA)?

U.S. Food and Drug Administration Definition

The U.S. Food and Drug Administration (FDA) establishes regulations to protect the public health. Specifically, the FDA inspects, tests, approves, and creates safety standards for foods, drugs, chemicals, cosmetics, household products, and medical devices. Under the FDA’s regulations, medical device and biotechnology companies must comply with 21 CFR Part 820, Part 11, and other quality system requirements (QSR) to be able to sell products in the United States.


What does FDA regulate?

The Food and Drug Administration (FDA) regulates human pharmaceuticals and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that produce radiation in order to protect public health. The FDA does not “”approve”” firms, and compounded pharmaceuticals are not approved. The FDA approves new pharmaceuticals and biologics and regulates medical devices using a risk-based, tiered system.

source: https://www.fda.gov

How does the FDA protect consumers?

The FDA regulates and approves products, issues recalls and safety alerts, and warns us about health scams and other health dangers in order to safeguard consumers and patients.

source: https://www.novatx.com

Why FDA approval is important?

The FDA’s approval is significant because it reinforces the need for more research into how medications operate in young people as well as adults. It also helps us to establish the proper dosage for children, the optimal route of administration, and screen for any drug interactions.┬áIn order for a drug or medical device to be approved by the FDA, the maker must demonstrate that it is both safe and effective. Although no drug or medical gadget is completely risk-free, research and testing must demonstrate that the drug’s or device’s benefits for a specific illness outweigh the dangers to patients.

source: https://www.healthychildren.org

Best Practices for Quality & Compliance

Read our guides to learn best practices on how to eliminate issues and risks and launch high-quality, compliant products to market.