The United States Food and Drug Administration (“FDA”) regulates a broad range of medical devices, from artificial hearts to tongue depressors. The FDA has the authority to regulate medical devices both before and after they reach the marketplace.
A “medical device” is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them; intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it’s primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
Not all medical devices require a prescription but many do, such as contact lenses. The FDA does not regulate who can write a prescription for a medical device — each state has laws and regulations establishing who can write a valid prescription for a medical device in that state.
FDA-Listed Medical Devices
Medical devices that are required to be reviewed by the FDA are called “FDA-listed.” Not all medical devices are required to be FDA-listed; those that are not required to be FDA-listed before they are marketed are called “510(k) exempt.”
A medical device is FDA-listed if the firm that manufactures or distributes the medical device has successfully completed an online listing for the device through the FDA Unified Registration and Listing System (FURLS).
Cleared Medical Devices
There are also “cleared medical devices” that the FDA has determined to be substantially equivalent to another legally marketed device. A premarket notification, referred to as a 510(k), must be submitted to the FDA for clearance, usually by the medical device manufacturer.
510(k) Exempt Medical Devices
“510(k) exempt” medical devices are mostly low-risk medical devices. Nonetheless, they must be suitable for their intended use; be adequately packaged and properly labeled; have establishment registration and device listing forms on file with the FDA; and, be manufactured under a quality system (with some exceptions).
Approved Medical Devices
Lastly, there are “approved medical devices” for which the FDA has approved a premarket approval (PMA) application prior to marketing. The process for approved medical devices is generally reserved for high-risk medical devices and involves a more rigorous premarket review than for the 510(k) process.
To find out if a medical device is approved or cleared, the FDA maintains a searchable database. You can also determine if a medical device is subject to a recall by using another searchable database.
If you have been injured by a medical device, a medical malpractice attorney may be able to answer your questions regarding a possible claim for your injuries. Our website can put you in touch with medical malpractice lawyers in your area who may be able to help you with your claim. Our toll free telephone number is 800-295-3959.