The FDA has released a list of examples of product communications consistent with agency-approved labeling for medical devices.
In draft guidance, the agency said sponsors may include information on safety and efficacy, including clinical trial data. The FDA said it considers labeling information on adverse reactions and a product’s effect in a subpopulation to be appropriate.
The agency emphasized that sponsors may not include information about unapproved uses. For example, a device that is cleared to diagnose a specific gene mutation for individuals with cystic fibrosis should not include information about its use for individuals who do not have the disease.
Device firms also should consider whether a modification to the indications for use would trigger the need for a new premarket submission. If the information a firm wants to communicate represents such a modification, it would not be consistent with the agency’s labeling policy.
In the draft guidance, the FDA explains the criteria it uses to determine whether a company’s communication is consistent with an agency-approved label. First it looks at whether the indication, patient population, and directions for use are inconsistent with the device label. Next it evaluates whether the communication increases the potential for health risks. In particular, it looks at whether the communication modifies the benefit-risk profile. Lastly, the agency assesses whether the indications represented in the communication allow for safe and effective use based on the label’s directions.