Compliance Auditing

Originally Published MX May/June 2002

GOVERNMENTAL & LEGAL AFFAIRS

Medtech manufacturers don't have to be unpleasantly surprised when FDA inspectors knock on their door.

Jeffrey N. Gibbs

Surprise parties and unexpected visits may be either pleasant or unwelcome, according to the eye of the beholder. But when regulatory surprises befall medical technology companies, they are nearly always unpleasant.

On occasion, a product will perform better in clinical trials than anyone anticipated. And once in a while, FDA will clear a device with unexpected rapidity. But generally speaking, surprises connected with the regulatory status of medtech manufacturers and their products are both unpleasant and undesirable.

Such regulatory surprises can manifest themselves in a variety of unwanted forms, such as FDA warning letters objecting to a company's advertising claims, product failures that necessitate a recall, or clinical investigators whose sloppy recordkeeping jeopardizes a company's product approval. Whatever their shape, they are virtually always unwelcome guests.