By Lacy Boggs
Since 1976, all medical devices must be classified and approved by the U.S. Food and Drug Administration
(FDA) before they can be legally marketed to the public. It is the fond
belief of many Americans that FDA approval is a ringing endorsement of a
product's safety, a guarantee that the device has been tested and
re-tested by professionals who are presumably trained to put the device
through all kinds of rigor to triple-check its safety and effectiveness
before allowing it anywhere near our fragile human bodies.
It
is, as we say, a fond belief, but not an accurate one. It seems that
many medical devices - including the recently recalled DePuy ASR XL
Acetabular System - are given an FDA approval and subsequently placed
inside people's bodies without ever going through a single test at the
FDA.
The FDA department responsible
for the regulation and review of medical devices is the Center for
Devices and Radiological Health (CDRH). CDRH divides medical devices
into three classes: life-sustaining, life-supporting or implantable
devices are designated as Class III.
Hip
replacements, including the ASR XL system, qualify as a Class III
device and are considered high risk to the patient's health.
Class III devices can be approved by the FDA through one of two processes. The first, the premarket approval process
(PMA) is more or less what we think of when we imagine our device being
tested by the FDA: an extensive review including rigorous clinical
trials that show it to be safe for use in humans. The PMA is quite
detailed, lengthy, and expensive, usually costing the manufacturing
company upwards of $250,000 and taking as much as two years to complete.
A quarter of a million is a large
chunk of change - but thankfully for companies with a firm eye on their
bottom line, there's always the second FDA approval process.
The premarket notification approval process, also known as the 510(k) approval process,
is a sort of shortcut to approval that lowers the price point
considerably - and also, conveniently, doesn't involve any pesky testing
that might reveal a flaw in the product that would then have to be
revamped and retested for another quarter-million.
The
510(k) process basically pre-approves any product that is deemed
"substantially equivalent" to another product already legally approved
for sale. It costs less than $5,000, requires no clinical trials, and
only takes an average of 3-6 months to complete. It's a good shortcut
for products that are essentially identical to their forebears. After
all, it hardly makes sense to waste the FDA's time when they could be
helping get new, innovative, life-saving products to market. But what's
to stop companies from claiming their products are "substantially
equivalent" to other FDA-approved devices even if they're not remotely
the same?
What, indeed
The ASR XL Acetabular hip replacement system
got its seal of approval from the FDA using the 510(k) process,
claiming that its product was substantially equivalent to other hip
replacement devices already on the market. The FDA official in charge of
approving the device would have gone through a checklist that included
the following questions (simplified; the actual document is fairly dense):
- Does the new product treat or solve the same problems as previously approved products?
- Does the new product have the same design, materials, and energy sources as previously approved products?
- Could any new characteristics or combinations of characteristics affect safety or effectiveness?
