Sunday, May 22, 2016

Your medical device may not be what you think.

What does it mean when FDA "clears" or "approves" a medical device?

When FDA review is needed prior to marketing a medical device, FDA will either:
"clear" the device after reviewing a premarket notification, or  "approve" the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.

To acquire clearance to market a device using the "clearance" process, the submitter must show that the medical device is "substantially equivalent" to a device that is already legally marketed for the same use.
To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.

Because of the nature of the laws underlying this process, a successful submission is deemed to be “cleared.” By legal definition, it is NOT an “approval” process.

Unfortunately, some manufacturers have obtained FDA clearance without revealing the actual use of the device. Once it is "cleared" for one use, they advertise it for another, claiming it is "cleared by the FDA."

So buyer beware when you see that medical wand that is advertised to make fungus vanish or your hair grow!  If the device is only "cleared" by the FDA, more research may be necessary to see if it is indeed effective for that claimed purpose.