What is FDA Compliance?

FDA Compliance Definition

FDA (Food and Drug Administration) compliance refers to the regulations set forth to protect the public health. FDA regulations help ensure the safety, efficacy, and security of drugs, medical devices, and biological products. Medical device and biotechnology companies must adhere to FDA 21 CFR Part 820, Part 11, and other quality system requirements (QSR) to be able to sell products in the United States.

What is a FDA Compliance


What does it mean to be FDA compliant?

To be FDA compliant, life sciences companies and medical device manufacturers must establish and follow current good manufacturing practices (CGMPs) for the design, manufacture, installation, and servicing of safe and effective products, as specified under Title 21 CFR Part 820. The necessary design controls must also be in place to ensure that products are safe and effective for their intended use. Under Title 21 CFR Part 11, manufactures must also demonstrate that electronic records are trustworthy, reliable and/or equivalent to paper records.

Why do you need FDA approval?

Medical device manufacturers must obtain FDA approval to market and sell their products in the United States. FDA approval is important, because it ensures that products have been tested for safety and efficacy and that all manufacturing practices and quality standards have been met prior to launch.

What is the main purpose of the FDA?

The primary role of the FDA is to protect public health by ensuring the safety, efficacy, and security of a variety of products including drugs, biologics, and medical devices.

*Source: fda.gov

How does the FDA ensure compliance?

The FDA classifies medical devices based on their intended use and the risk that they pose. Depending on the classification, the FDA may require manufacturers to submit extensive clinical trial data, or detailed technical, safety, and performance information about the device to obtain premarket approval or clearance. The FDA also conducts routine audits to assess various components of the manufacturer’s quality management system (QMS) including design controls, corrective and preventive actions (CAPAs), and production and process controls.

*Source: meddeviceonline.com

The Cost

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