FDA Certificate

What is the FDA?

The FDA (Food and Drug Administration) is the United States federal agency responsible for protecting public health. Operating under the U.S. Department of Health and Human Services, it regulates and monitors food products, medicines, and medical devices. Founded in 1906, it is the world’s oldest consumer protection agency. The FDA sets strict safety and hygiene standards for products that come into contact with food and drinking water.

To legally sell products in the United States, a company must obtain FDA approval. Every food exporter to the U.S. is required to register with the FDA and comply with food safety protocols and hazard analysis procedures.

Main responsibilities of the FDA

• Protect and manage public health and related bodies (e.g., the CDRH regulates laser technology; safety standards are defined by the CFR – Code of Federal Regulations)

• Ensure the safety, effectiveness, and quality of food, medicine, and medical products

• Monitor hygienic standards for food, drugs, and medical devices

• Audit production plants, processes, and materials used in manufacturing, packaging, and storage

• Regulate products such as biologics, over-the-counter and prescription drugs, veterinary drugs, cosmetics, and radiation-emitting devices

What is the FDA Certificate?

An FDA certificate is a formal document confirming that a product has been approved according to U.S. regulations. It verifies that the product complies with established safety standards and has passed all necessary inspections, tests, and quality controls related to manufacturing processes.

What does the FDA regulate?

FDA certification guarantees a product is safe, effective, and meets all applicable U.S. legal requirements—even if it already has a CE mark. The FDA oversees:

• Chemical and biological drugs (including vaccines, gene therapy, and blood products)

• Medical devices (e.g., heart valves, stents)

• Human cells and tissues

• Tobacco products (must display health warnings approved by the FDA)

• Animal medications

• Food products (excluding poultry, livestock, and eggs, but includes bottled water production)

• Colour additives (in cosmetics and medicines)

• Radiation-emitting products (such as microwave ovens)

FDA approval indicates a product is safe for use. However, the agency does not approve infant formula, medical foods, dietary supplements, or cosmetics.

Benefits of FDA Approval

As a globally recognised authority, the FDA ensures the safety and efficacy of food, medical products, and pharmaceuticals. Advantages of FDA certification include:

• Access to international markets (FDA approval is respected worldwide)

• Increased consumer confidence

• Enhanced product safety

• Assurance of high-quality standards

• Compliance with rigorous testing and regulations

Products with FDA approval—such as uric acid monitors or veterinary coagulation analysers—are trusted by consumers due to their proven reliability and safety standards.

Learn more about FDA-compliant materials and FDA-approved food-grade O-rings available at Power Rubber.

FDA vs. CE Mark

FDA approval allows a product to be marketed in the U.S., while the CE mark is required for sales in EU member states. For medical devices, both certifications follow a risk-based classification system. The CE mark confirms that a product complies with EU safety and quality directives, though it does not apply to food, medicines, or cosmetics. Ideally, manufacturers should aim to obtain both approvals.

FDA certification is granted after a comprehensive verification process, such as quality control testing for medical devices.

FDA Certification for Medical Devices

An FDA-approved medical device or pharmaceutical is recognised globally as a symbol of quality and safety. Certification confirms that the product is effective and does not pose a risk to health.

FDA Medical Device Classification:

• Class I (low risk): breast pumps, bandages, examination gloves, glucose and uric acid test strips

• Class II (moderate risk): dialysis equipment, catheters, powered wheelchairs

• Class III (high risk): mechanical heart valves, implantable infusion pumps, breast implants. These require premarket approval (PMA), including evidence of safety and efficacy

Specialist medical stores often offer equipment for people with diabetes or gout. Home-use devices such as lancets, respiratory failure analysers, lipid profile monitors, or atrial fibrillation detectors must provide reliable results and be certified safe for consumers. Many of these tools are FDA-approved and user-friendly.

To receive FDA certification, a company must prove that its drug or biologic is both safe and effective. All FDA-approved products must be manufactured according to strict quality standards. Certification costs vary depending on product classification.

For more information, feel free to contact us at:
Tel: +48 22 292 40 24 or +48 505 16 03 03
Email: Power@PowerRubber.com
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