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Product Index & Information

• Index of consumer topics
• What is a medical device or radiation emitting product?
• Recently approved devices
• Learn if a medical device has been cleared/approved by FDA for marketing

What is a medical device or radiation emitting product?

A medical device is:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease." Medical devices can be anything from thermometers to artificial hearts to at- home pregnancy test kits.

(source: Federal Food, Drug and Cosmetic Act, Section 201)

Radiation-Emitting Products include:

such things as microwave ovens, televisions, sunlamps, medical and baggage inspection x-ray machines, lasers, CT/MRI scans, diagnostic ultrasound, laser light shows and bar code scanners.

(soucre: 21 CFR Part 1000.15 )

To search for one of the products, use the Index of consumer topics.

Recently Approved Devices

Why does FDA approve medical devices before they can be sold?

Before granting approval to manufacturers to sell their new devices, FDA science experts review the manufacturer’s data from investigational studies to see if:

• the product does what it claims to do effectively, and
• does not present any unreasonable risks to the patient.
  

Where can I find more information about these products?

Today there are many sources of information about medical devices and procedures including information on the internet from health care organizations, medical centers, and consumer organizations. One accurate source of information about the risks and benefits of the product is patient labeling prepared by the manufacturer and reviewed by FDA. Patient labeling is available for many of the devices listed on the Recently Approved Devices page

Are all medical devices listed on the Recently Approved Devices page?

No. Only devices that have gone through FDA’s premarket approval process and were approved after May 12, 2000 are listed on this page. The majority of medical devices are cleared through the premarket notification process, a less rigorous process. Some devices are exempt from both processes. More information about FDA’s regulatory processes is available at http://www.fda.gov/cdrh/consumer/geninfo.html

For more information on medical devices that were approved before May 12, 2000 or were cleared through the premarket notification process, please use our on-line search of the Premarket Approval (PMA) records or the on-line search of the Premarket Notification 510(k) records

Updated 3/19/2002