Guess which medical device has the toughest federal regulation:
a) surgical lasers.b) heart defibrillators.
c) anesthesia machines.
d) contact lenses.
The answer is contact lenses, by far. They are grouped with devices considered life-supporting or presenting a "potential unreasonable risk of illness or injury." The other devices listed are not deemed as hazardous and have less supervision.
That's ridiculous, according to Senate testimony Wednesday by Utahn Earl Saltzgiver - the owner of Foremost Contact Lenses, representing an association of small contact lens makers - and by Sen. Orrin Hatch, R-Utah.
They said the extra regulation and paperwork artificially inflate the cost of lenses and help large companies - which can better absorb such costs - force smaller ones out of business.
They also told the Senate Labor and Human Resources Committee - on which Hatch is the ranking Republican - that it prevents the Food and Drug Administration from devoting more of its tight budget to overseeing medical devices that truly need it.
Congress is considering a medical device bill that would, among other things, require less stringent oversight of now commonplace "rigid gas permeable" contact lenses.
Saltzgiver said such lenses are an improved variant of now obsolete "hard" lenses that permit oxygen to diffuse directly through them to the eye to give greater comfort and health.
He said "Class III" oversight of such lenses - the strictest under law - was not intended for such devices. "It is not surprising that Class III accounts for only about 7 percent of all medical devices. Examples are heart valves and pacemakers."
He said the FDA and smaller companies that make contact lenses have long proposed changing rules to allow less stringent oversight, which the FDA said requires a wording change in the 1976 Medical Device Amendments.
However, larger contact lens companies have opposed such a change. Saltzgiver said suggesting lenses "cannot be safely regulated in Class II along with heart defibrillators, anesthesia machines, artificial joints and surgical lasers is - of course - preposterous."
He suggested the larger companies opposition comes because they worry the changes would make smaller companies more competitive.