By Richard Felten, Mitchell Levinson,
and Eric F. Bernstein, M.D.
Supplement to Skin & Aging ■ January 2006
http://www.skinandaging.com/supplements ... ersies.pdf
Just because a product is cleared by the FDA does not necessarily mean that the safety and efficacy have been demonstrated in a clinical trial. This true statement has, no doubt, been the source of bewilderment and, possibly, anger for many dermatologists. How can this be possible?
The traditional 510(k) approval process does not require a device manufacturer to perform clinical trials with the device.
Under this type of approval, a company must compare its device’s materials, technological characteristics, function, and
the indications for use to the predicate device. The predicate device is considered the first device approved in a specific category (e.g., the carbon dioxide [CO2] laser is the predicate for all wrinkle-removal devices). So companies with laser and light devices seeking approval for the indication of wrinkle removal must compare their devices to the CO2 laser.
For example, say a company is seeking approval for a new intense pulsed light (IPL) system that is similar to other IPL systems
that are legally marketed in the United States. To attain 510(k) approval for the new IPL system, the manufacturer could
compare the energy per square centimeter and the device’s wavelength to the predicate device.