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Risk-based Approach -FDA Approved Pt 3

It is not uncommon for people to take notice on product labels, company websites, commercials promoting a new product or treatment or hear some marketers saying the word’s “FDA approved!” What does that even mean and is it really FDA approved? How can you know for sure what the US Food and Drug Administration approves? This article and subsequent articles will look at how the FDA regulates products and what it does and doesn’t approve. the focus is on the use of a risk-based approach to approval.

FDA uses a tiered approach for regulating medical devices

The FDA classifies devices according to the associated risk. The highest risk devices, such as mechanical heart valves and implantable infusion pumps are classified as Class III. Therefore, these devices generally require FDA approval of a premarket approval application before marketing. However, for FDA approval for such devices, manufacturers must demonstrate that there is a reasonable assurance of device safety and effectiveness.

Moderate risk medical devices, for example dialysis equipment and many types of catheters, are classified as Class II. Therefore, FDA clears devices for marketing if they demonstrate that the device is substantially equivalent to a largely marketed device. However, largely marketed device does not require premarket approval.

Devices that present a low risk of harm to the user are classified as class I. For example, non-powered breast pumps, elastic bandages, tongue depressors and exam gloves. Thus these devices are subject to general controls only and most are exempt from premarket notification requirements.

FDA uses a risk-based approach for human cells and tissues

All human cells and tissues to be used in humans are regulated to prevent the transmission of infectious diseases. Such human cells and tissues are collectively referred to as human cells, tissues and cellular and tissue-based products. Additionally, cells and tissues that pose an additional risk also require FDA approval before marketing. Some examples of cells and tissues include:

  • Bone
  • Skin
  • Corneas
  • Ligaments
  • Tendons
  • Dura mater
  • Heart valves and
  • Reproductive tissue



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