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FDA's RoleWhat's NewFDA’s AuthorityFDA 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:
FDA monitors the ongoing safety and efficacy of all regulated marketed devices, through these problem reporting programs:
FDA-Approved Lasers for LASIKFor details on which lasers have received FDA approval, search our list of FDA-approved lasers for LASIK. This list provides you:
This list does not include FDA cleared laser keratomes. Please note that new listings are not added until approximately five working days after the last day of the month in which the device was approved. In some cases, it can take as long as five weeks to appear. Updated September 17, 2008 |
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