WHAT THE FDA REGULATES?

In the United States, the Food and Drug Administration (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 "indication." Once the FDA has approved a medical device, a doctor may decide to use that device for other indications if the doctor feels it is in the best interest of a patient. The use of an approved device for other than its FDA-approved indication is called "off-label use." The FDA does not regulate off-label use or the practice of medicine.

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.

The first refractive laser systems approved by FDA were excimer lasers for use in PRK to treat myopia and later to treat astigmatism. However, doctors began using these lasers for LASIK (not just PRK), and to treat other refractive errors (not just myopia). Over the last several years, LASIK has become the main surgery doctors use to treat myopia in the United States. More recently, some laser manufacturers have gained FDA approval for laser systems for LASIK to treat myopia, hyperopia and astigmatism and for PRK to treat hyperopia and astigmatism.

Visit FDA for a list of FDA-approved lasers for more details on which lasers have received FDA approval and the specific indications and treatment ranges for which they were approved.

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