160 • Alternatives to Animal Use in Research, Testing, and Education 
animal drug” is defined as one not "generally rec- 
ognized as safe” and effective. It must be tested 
to demonstrate both safety and effectiveness be- 
fore marketing is permitted. 
Medical Devices 
i 
Extensive regulatory provisions relating to the 
safety and effectiveness of medical devices for hu- 
mans were enacted in 1976 (21 U.S.C. 321). For 
devices available before then, FDA may at any time 
require that proof of safety and effectiveness be 
submitted. For post-1976 medical devices that are 
substantially equivalent to those for humans be- 
fore 1976, the same rule applies. But for those not 
substantially equivalent, testing must be under- 
taken to prove both safety and effectiveness, a pre- 
market approval application must be submitted 
to FDA, and FDA must approve the device as safe 
and effective before it may be marketed. Because 
of the diversity of medical devices, the testing re- 
quired is tailored specifically to the product in- 
volved and there are relatively few guidelines. 
As the materials involved and methods of appli- 
cation are often unique, determining the safety 
of medical devices from the standpoint of toxicity 
presents special problems. Consequently, recom- 
mendations for specific tests are based on an evalu- 
ation of the following factors: 
• the population for which the device is in- 
tended, with special reference to the target 
group’s age and sex, and the benefit to be 
derived; 
• the intended use of the device and its poten- 
tial to contact the body or, for leachable or 
absorbable materials, to be distributed in the 
body; 
• the location of the device in the immediate 
vicinity of various organs that might be ad- 
versely affected by its presence; 
• the size of the device and the amount of 
leachate potentially available to the body; and 
• chemical or toxicological information suggest- 
ing the potential for adverse toxic effects, such 
as when a leachable substance belongs to a 
chemical family that contains compounds with 
known potential for these effects. 
Requirements for testing ophthalmic devices and 
products, color additives used in devices, and fe- 
male contraceptive devices are more standardized. 
For color additives used in devices, the same types 
of tests are recommended as for color additives 
used in foods. For female contraceptive devices, 
the requirements are the same as those used for 
contraceptive drugs. 
Medical devices for animals may not be mis- 
branded or adulterated either. Testing can involve 
animals and is undertaken to substantiate label- 
ing claims and safety. The law does not require 
premarket approval of such devices, however. 
Cosmetics 
Although the law prohibits misbranding or adul- 
teration of cosmetics, FDA has no statutory au- 
thority to require testing of cosmetics for safety 
(other than their color additives) before they are 
marketed. However, animal testing is commonly 
undertaken to substantiate labeling claims and, by 
regulation, FDA has stated that any cosmetic with 
an ingredient that has not been substantiated for 
safety or that itself has not been substantiated for 
safety in its final product form must bear a promi- 
nent label declaration that the safety of the prod- 
uct has not been determined. 
Color Additives 
The law requires that any color additive used 
in food or drugs for animals or humans, in medi- 
cal devices for humans, or in a cosmetic must be 
proved safe; must be the subject of a color addi- 
tive petition filed with FDA; and must be deter- 
mined by FDA to be safe before it is used (2 1 U .S .C . 
321 et seq.). Color additives in use at the time of 
the enactment of this provision in 1960 have been 
placed on a provisional list and are subject to the 
same requirements for testing and approval as 
post-1960 color additives. 
Radiological Products 
The law authorizes FDA to regulate the emis- 
sion of radiation from electronic products through 
the establishment of performance standards and 
a program of research and other activities to min- 
imize human exposure . Testing on electronic prod- 
uct radiation is undertaken both in relation to pro- 
posed and promulgated performance standards 
and to determine other aspects of potential haz- 
ard for humans from such emissions. 
