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The FDA review process imposes significant delays upon the

marketing of new devices.

A Brief History of Medical Device Regulation

The fundamental sanctioning law of the FDA, the Federal

Food, Drug, and Cosmetic Act of 1938 (FDC Act), clearly

separated medical devices from pharmaceuticals and gave the

FDA power of premarket approval over pharmaceuticals but

gave it no corresponding power over medical devices.

("Pharmaceuticals" are products that produce an effect

through chemical or metabolic action.  "Biologics" are prod-

ucts of biological origin that have pharmaceutical proper-

ties.) A "medical device," according to the General Account-

ing Office (GAO), "can be any product used to cure, prevent,

diagnose, or treat illness, provided that its principal

intended purposes are not achieved primarily by chemical or

metabolic action."27  Devices range from Band-Aids and

tongue depressors to kidney dialysis units and heart lung

machines.

Under the 1938 law, the FDA's options for regulating

devices were limited to asking the courts for the authority

to block new devices or to remove existing devices from the

market.  Within that limited sphere, the FDA blocked or

removed dozens of fraudulent medical devices during the next

quarter century.  Following passage of the 1962 amendments

to the FDC Act, which expanded the FDA's mandate to require

proof of effectiveness as well as safety for drugs and which

increased the FDA's enforcement powers, the FDA struggled to

secure the same authority over medical devices that it al-

ready had over drugs.28

The Medical Device Amendments of 1976 enjoined the FDA

to "provide reasonable assurance of the safety and effec-

tiveness of the device[.]"  Safety and effectiveness were to

be determined with respect to the device's intended user,

its prescribed or recommended uses, and its probable benefit

weighed against the probable risk of illness resulting from

its use.

The most significant aspect of the 1976 amendments was

the establishment of the FDA as the gatekeeper over market

access for medical devices.  Power had clearly shifted to

the FDA.  Instead of being required to demonstrate its case

to the satisfaction of a court, the FDA could now ban devic-

es on its own legal authority, and it was left to the in-

jured party to seek a judicial review.