Amendments Bolster Preemption Defenses for Drug and
Medical Device Manufacturers
On August 22, 2008, the FDA published a final rule in the
Federal Register entitled "Supplemental Applications
Proposing Labeling Changes for Approved Drugs, Biologics, and
Medical Devices." The final rule modifies 21 CFR Parts
314, 601 and 814. The FDA's stated objective in
promulgating the final rule is to codify the FDA's
"longstanding view concerning when a change to the
labeling of an approved drug, biologic, or medical device may
be made in advance of the agency's review and approval
of such change . . ." Specifically, the final rule
addresses the supplemental application process for labeling
changes of approved drugs, medical devices and biological
products as described in §§ 314.70(c), 814.39(d) and
601.12(f)(2), which are commonly known as the "changes
being effected (CBE) supplements."
