FDA Cleared, Listed, or Approved Pharmaceutical and Medical Products

Posted by in Medical Product Issues on Oct 13, 2016

Is the drug you are taking or the medical device used during your treatment FDA approved? Strictly speaking, only drugs and life-sustaining or life-threatening “Class 3” medical devices, such as replacement heart valves and defibrillators, hemodialysis machines, orthopedic implants, which require the highest level of regulatory control due to the very high risk of using these, need to be approved by the U.S. food and Drug Administration before these can be marketed. Class 3 drugs and medical devices need to be subjected to a strict review process called “pre-market approval” (PMA) to prove that their benefits outweigh potential risks to patient health.

The product’s manufacturer should provide the FDA with scientific evidence from clinical trials which will show the product’s safety and effectiveness. Over-the-counter drugs, which are assumed to be safe, require less rigorous testing procedure, while herbs, vitamins and supplements do not need to be tested, unless these are used as active ingredients in a drug that necessitates FDA approval; due to this, supplements can only claim that they can be used for the promotion of health, not for the treatment of any specific disease.

“Class 2” medical products, such as X-ray machines, ultrasound scanners, powered wheelchairs, pregnancy test kits and contact lenses, also require regulatory control but not as stringent as in Class 3 products. Class 2 products need only FDA clearance before these can be sold. Also, instead of submitting the product to clinical trial, the product’s manufacturer only needs to convince the FDA that the product is “substantially equivalent” to one that has already been cleared in the past.

By “substantially equivalent,” it means that the product has, approximately, the same technical characteristics and intended use as an existing product. Passing this clearance process means that the product is “FDA listed” or “FDA cleared.”

Despite the tests and/or regulatory control, many defective and harmful products continue to find their way into store shelves to be displayed and bought by unsuspecting consumers. This usually happens after the manufacturer of a defective product hides information on the dangers associated with the use of their product or fails to warn doctors and patients about their product’s harmful side effects.

According to a Milwaukee injury attorney, medicine may be considered defective or dangerous because of: incorrect or misleading labels, poor manufacturing quality or flawed package design. If use of a defective product results to injury to consumer, then the pharmaceutical company and/or medical manufacturer should be held liable for the damages that their product has caused in those who used it.

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