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The next significant event in medical device regulation

was the November 1990 passage of the Safe Medical Devices

Act (SMDA).  The pattern repeated itself.  The FDA garnered

more power, added more layers of costly reporting and bu-

reaucratic requirements, and gained more powers of interfer-

ence in the market.  The SMDA instituted a massive system of

post-market surveillance and a reporting scheme wherein

medical device users, of any sort, are required to file

reports anytime a device could be implicated in a patient's

injury or illness.  Often hastily written, these reports are

seldom-useful research tools.  The FDA requires users to

decide for themselves when such a report is necessary.29  In

addition, the FDA received new authority to impose civil

penalties for violations of the Act, or not to impose the

penalties, at the FDA's discretion.

Classes and Tiers and What Difference Do They Make?

The 1976 amendments established three classes of medi-

cal devices (Classes I, II, and III), corresponding to

devices of low, medium, and high risk.  In 1994, the FDA

implemented a three-tier system that ranks devices according

to the intensity of required review.  Tier I devices require

the least review.  With the combination of the class and

tier systems, the FDA can categorize medical devices in nine

different ways (e.g., Class I, Tier I; Class II, Tier I;

Class III, Tier I; Class I, Tier II; Class II, Tier II,

etc.).

Some devices are novel, and some devices are similar,

or nearly equivalent, to existing devices.  For high-risk

novel devices, the FDA requires a full pre-market approval

(PMA) review before allowing the marketing of the device.

Low-risk novel devices similar to other approved devices are

evaluated under a provision called "510(k)" (after a section

of the 1976 law).  The 510(k) process initially required

only that the manufacturers notify the FDA about the device

and convince the agency that it was equivalent to an exist-

ing device.  The FDA does not require full PMAs before

considering approval for new uses of approved devices.

Those are evaluated as "PMA supplementals" and require only

an abbreviated approval process.

These neat distinctions, if they ever existed, have

been battered down by the FDA's constantly expanding re-

quirements.  The 510(k) process, through arbitrary and baf-

fling FDA requests for more information, ballooned from a

simple notification process into a system often tantamount

to a full PMA.  Former FDA chief counsel Peter Barton Hutt