Although most medical device companies focus the bulk of their regulatory resources on compliance with federal requirements imposed by the Food and Drug Administration (FDA), a significant portion of device regulation falls within the purview of state agencies, particularly with respect to device distribution.
State regulation in this area has long been a significant burden for companies that market and distribute devices nationally. Currently, approximately half of the 50 states regulate the distribution of devices, but the laws regulating device distribution vary from state to state.