The Medical Device Act did not preempt a state law duty to warn products liability claim with respect to an intervenous blood filter. The FDA had reclassified IVC blood filters as Class II devices that were subject to three requirements applicable to all IVC blood filters. Since the MDA preempts only state laws adding to or changing FDA requirements for a specific medical device, these requirements applicable to a whole class of devices did not preempt state law. Also, the FDA requirements had nothing to do with any warnings to be given iwth the devices and so did not preempt the failure to warn claim.