Welcome to Compliance Consultants...

...the more you learn...the more you will want us for FDA!

Labeling...

Surely no other subject has received more paper than Labeling. The definitions are scattered throughout hundreds of FDA documents. This highlights labeling over many projects.

These general guidelines define the requirements for a medical device:

· A consumer cannot be confused as to the source of the good.

· The manufacturer's label must define a unique product that can be traced back to the original manufacturer or distributor.

· The manufacturer's label must state exclusions, ratings, warnings and safety data..

· Prescription only devices must be labeled as such.

· Goods must bear country of origin.

· Labels must endure through the life on the device.

· Ancillary goods must be marked to ensure proper association to the device.

The FDA views the labeling (user instructions) as equally important as the performance of the product. The labeling and instructions are as fundamental as the design of the product.

Consider a bottle of aspirin and the corresponding label. Either of these can be considered "adulterated" by the FDA. The aspirin (substance) could contain arsenic and that "adulteration" (poison) could cause the patient's death. On the other hand, the label could contain an error and misstate: take 100 aspirin instead of 1. That "adulterated" could also cause death. The same result (death) occurs for either "adulteration". This is an exaggeration to amplify the effects of either a product or label "adulteration".

The FDA views each "adulteration" as potentially serious. The trades-offs are: "risk" versus "cost". Since labels are cheap but at high risk for causing an undesired effect the FDA is very serious about: · design of the labeling. · results of the labeling. · control of the labeling.

We define labeling in a general sense as all the words that are made available from the manufacturer to the user or patient regarding a product that was purchased or how the product is used.

Labeling includes an advertisement, but excludes a magazine article.

Labeling includes a user's manual, but excludes scientific papers presented at symposiums.

Labeling includes claims made by salesmen who distribute the products, but excludes scientific speeches made at scientific meetings.

Many incidents reported to FDA involve a labeling infraction or misuse. Enforcement of labeling for both drugs and devices is paramount at the FDA. The FDA has established a consistent position that an "adulteration" in labeling is considered with the same potential seriousness as "adulterations" in the substance. Serious attention to labeling is one of the cheapest ways to improve your position with the FDA.

copyright by Compliance Consultants, Stamford, CT USA, September 2001