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.