FDA Basics You Should Know

• January 16, 2017
• FDA, Product Liability

The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

What this means, is that the FDA:

• Ensures that the food we eat is safe
• The cosmetics we use won’t harm us
• Medicines, medical devices and radiation-emitting consumer products are safe and effective

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FDA Product Approval

Products such as new drugs and complex medical devices must be proven safe and effective before companies can put them on the market, while other products such as microwave ovens must measure up to performance standards.

The FDA does not develop nor does it test products. They review and rely on the results of laboratory, animal and human clinical testing done by the companies to determine if the product is safe and effective.

The FDA does a pre-market review for:

• new human drugs and biologics (such as vaccines, blood products, biotechnology products and gene therapy)
• complex medical devices
• food and color additives
• infant formulas
• animal drugs

As much as we would like to think so, no regulated product is totally risk-free so oftentimes the FDA’s medical product evaluation decisions can be a judgment about whether a new product’s benefits will outweigh its risks to the consumer.

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FDA-Approved or Not

The FDA does not approve health care facilities, laboratories, or manufacturers. What they do is inspect product manufacturers to ensure they comply with good manufacturing practices.

The FDA does approve new drugs and biologics since these need to be proven safe and effective before being marketed. If the FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.

The FDA uses a risk-based, tiered approach for regulating medical devices, classifying medical devices as Class I, II and III. The class a medical device is assigned determines the type of premarketing submission/application required for FDA clearance to market.

• Devices classified as the highest risk devices (i.e., Class III) require FDA approval before marketing.
• Moderate risk medical devices (i.e., Class II) are cleared for marketing based on an FDA determination that they are substantially equivalent to an already legally marketed device of the same type.
• Low-risk devices (i.e., Class I) are typically exempt from premarket notifications

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Report a problem with an FDA-regulated product

If you have a concern or want to report a problem to the FDA, use the MedWatch Voluntary Reporting form. Check in at the FDA website for the appropriate avenue and for what to use the MedWatch form for.

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Searching for Product Recalls

• Recalls, Market Withdrawals & Safety Alerts: information gathered from press releases and other public notices about certain recalls of FDA-regulated products
• Medical Device Recalls
• List of Device Recalls
• Recalls, Corrections and Removals (Devices)
• Drug Recalls
• Approvals of FDA-Regulated Products: approval information by product type

Learn more about Product Recalls.

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LEGAL EXPERTISE FOR PRODUCT RECALLS

The attorneys and legal team at Nash & Franciskato Law Firm in Kansas City are dedicated to representing people injured by defective products.

Our attorneys use our extensive resources to research and investigate every aspect of your situation. Our law firm has a solid reputation with a network of professionals who can provide dependable expertise useful in building your case for the compensation you deserve.

RECEIVE A FREE EVALUATION

If you or a family member is suffering adverse effects from the use of a defective product, contact our legal team in Kansas City today for your free, no-obligation case evaluation. Your health may be at stake, and our lawyers want to help.

Contact us

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Past results afford no guarantee of future results and each case is different and is judged on its own merits. The choice of a lawyer is an important decision and should not be based solely upon advertisements.