FDA Finalizes Guidance on Medical Product Communications

The FDA finalized guidance on medical product communications that are consistent with FDA-required labeling, presenting a three factor test to determine whether a communication is consistent with labeling requirements.

The test asks firms to determine if the conditions of use described in the communication are consistent with product labeling; if the communication alters the product’s risk-benefit profile in a possibly harmful way; and if the product labeling allows the product to be used safely for the conditions described in the communication.

The guidance provides examples of ways manufacturers can use its three-factor test to determine if a communication is consistent with required labeling.