New medical devices go through rigorous testing and clinical trials

Dr. Jeff Hersh

Q: Does the FDA regulate medical devices or only drugs? If it does regulate them, is this preventing new inventions?

A: Yes, the FDA closely regulates medical devices, as it does medications. In general, the FDA requires medical device manufacturers to show that their products are safe and effective (similar to what is required for medication approval), which is noted to mean:

“There is reasonable assurance …. based upon valid scientific evidence, that the probable benefits to health from use of the device …. outweigh any probable risks.”

There are different pathways to get FDA approval. 

Dr. Jeff Hersh

For medications:

  • A new (“novel”) medication must go through rigorous testing and clinical trials (as the COVID vaccinations had to) to get approval (even though due to the pandemic emergency the initial authorization of the COVID vaccines was allowed with an Emergency Use Authorization, there is now full approval).
  • A generic version of an established medication may only need to do an Abbreviated New Drug Application to show their medication is equivalent to the marketed medication. 

For medical devices it is conceptually similar with:

  • New (“novel”) devices requiring rigorous testing and clinical trials.
  • Devices that are ‘substantially similar’ to already approved devices (for example a new model of an x-ray machine) being approved after demonstrating ‘substantial equivalence.’


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