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Home > Blog > Defective Medical Device > Understanding The Difference Between FDA Approved and FDA-Cleared Is Crucial to Defective Medical Device Litigation

Understanding The Difference Between FDA Approved and FDA-Cleared Is Crucial to Defective Medical Device Litigation


In general, the Food and Drug Administration (FDA) regulates the following products: Biologics; Cosmetics; Some Dietary supplements; Food additives; Infant formula; Medical devices (the FDA places them in one of three categories; class I, II, and III); Over-the-counter drugs; Prescription drugs; Products that emit radiation; Surgical implants; and Tobacco products.

When it comes to understanding defective medical device litigation, it is crucial to understand the difference between FDA “approved” and FDA “cleared,” especially as we see more and more consumer tech devices enter the market. This is because the distinction between approved and cleared is significant: While FDA-approved means that the FDA has decided that the benefits of the product outweigh the known risks and manufacturers have to submit a pre-market approval application–as well as clinical testing results–in order to get approved, FDA-cleared means that the manufacturer is able to demonstrate that the product is “substantially equivalent” to another similar legally market device that has already been approved (i.e. a “predicate”).

Medical Devices, Specifically

The FDA places medical devices specifically into one of three categories: Class I (lowest risk), II, and III (highest risk). Examples include the following:

  • Class I: Bandages, enema kits, etc. Approximately 93 percent of these are exempt from premarket review;
  • Class II: powered wheelchairs, some pregnancy tests, etc. Most require premarket notification via 510(k);
  • Class III: breast implants, pacemakers, etc. Require premarket approval or humanitarian device exemption.

If a device is considered to be “exempt,” a manufacturer does not need to submit a premarket notification submission (510(k)) to obtain clearance before marketing the device. Examples include mercury thermometers, heating pads, bedpans, etc. Still, manufacturers must register and list them with the FDA.

Why This Matters

When it comes to “cleared” products, manufacturers simply submit a pre-market notification submission to the FDA and once that the agency clears that it is substantially similar to a predicate, it is cleared and can market and sold. However, companies are sometimes accused of getting their products cleared by using products that were already recalled for safety reasons; meaning that the FDA approval does not automatically protect the company against litigation The FDA also does not conduct its own testing, but rather relies on test results from other, independent labs.

Contact Our Texas Defective Medical Device Attorneys

Even if you as a company have done everything right in terms of submitting the paperwork necessary for your product, it is still entirely possible to get sued for marketing a defective product due to the FDA’s system. If this happens, you need to work with an experienced defective medical device attorney to ensure that you are protected. Contact our experienced Brownsville defective medical device lawyers at Colvin, Saenz, Rodriguez & Kennamer, L.L.P. today to find out more about our services.





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