The FDA was created to challenge huckersters and song & dance men.
Much of the problems that caused Congress to create the FDA were due to those people
in a rush to make quick money and delivered less than what they claimed.
The United States Food & Drug Administration is created as a political organization
more than a scientific organization. For example, the National Aeronautic and Space
Administration becomes a partner with industry in the exploration of space.
Not so with the FDA.
The FDA was set up as a watchdog agency. FDA was created as an oversight, advisory organization
to enforce food and drugs (and now devices). The first Food and Cosmetic
Law was to stop the snake oil salesman who promised a special tonic would grow hair.
That sets up one of the primary issues of the FDA enforcement: claims and labeling.
We are very serious about labeling since the FDA expects us to be. The first mission of the
FDA was to challenge fraudulent labeling. This matured into a detailed approval process.
Later as children sat close to color televisions in the 1960's, concern over uncontrolled
radiation caused the Radiological Health Act of 1968. That started the FDA scrutiny over
medical devices which created three classes of medical products.
Aspirin is metabolized by the body. The FDA classifies aspirin as a drug. Devices are things
(materials) not metabolized by the human body. Contact lens are a good example.
They are classified as a device. X-ray systems are also classified as devices.
The FDA classifies medical devices into three Classes: I, II & III.
You must achieve FDA permission to sell a medical device in the United States. This starts
when you submit an application. You must submit either a , 510(K) application
for a Class II device
or a Pre Market Approval application for a Class III device. If (when) the FDA responds
favorably, you would receive a "determination of substantial equivalence" for a Class II
device or an "approval" for Class III devices. A 510(K) marketing clearance ("determination
of substantial equivalence") is not an approval. The FDA does not approve a Class II device.
Only Class III (Pre Market Approvals) applications that include a Clinical Trial result in an
"approval".
How the FDA treats medical devices
is different from the European system. This distinction is often misunderstood.
The FDA considers how well the device applies to the medical application. The FDA considers
what the patient receives after the device is used. Was it safe? Was it effective? Was it
developed according to design controls? Will the manufacturer be capable of repeating the
manufacturing of the device?
The Europeans do not look at effectiveness with the same requirements as does the FDA. The
EC mark looks at safety. The EC mark resembles more a compliance testing approval to a precise
standard than an analysis of the effectiveness.
The FDA views ISO compliance as to be indicative of meeting FDA requirements -but ISO is not
a substitute for FDA approval. The FDA does not officially recognize ISO-9000. To do so would
remove the scrutiny powers away from the FDA.
To review many FDA topics, go to the top of this page and select "details about what the
FDA wants".
Copyright by Compliance Consultants, Stamford, CT 06907 USA, September 2001
