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U.S. Department of Health and Human Services

Medical Devices

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FDA's Role

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 FDA’s Authority

FDA regulates the sale of medical devices in the U.S. and monitors the safety of all regulated medical devices.

In the U.S., FDA regulates the sale of medical devices such as the lasers used for LASIK. Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA. To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use.

The FDA does not have the authority to:

  • Regulate a doctor's practice.  In other words, FDA does not tell doctors what to do when running their business or what they can or cannot tell their patients.
  • Set the amount a doctor can charge for LASIK eye surgery.
  • "Insist" the patient information booklet from the laser manufacturer be provided to the potential patient.
  • Make recommendations for individual doctors, clinics, or eye centers.  FDA does not maintain nor have access to any such list of doctors performing LASIK eye surgery.
  • Conduct or provide a rating system on any medical device it regulates.

FDA monitors the ongoing safety and efficacy of all regulated marketed devices, through these problem reporting programs:

  • MedWatch, the FDA Safety Information and Adverse Event Reporting Program. MedWatch allows reporting of serious problems related with drugs and medical devices from:
  • SightNet is a program through which health care professionals at participating facilities can share concerns about potential safety issues with ophthalmic medical devices, and report problems to FDA.