FDA Finalizes Q&A Guidance Docs On Manufacturer Communications, Adding A Few More Details

Two newly finalized guidance documents from US FDA help broaden the scope of acceptable manufacturer communications. One addresses communications with payers, while the other discusses communications that are consistent with approved labeling.

Many hands showing different ways of communication like mail, phone or internet

A recent move by US FDA clarifies protections for manufacturers that might want to discuss a device treatment regimen with an insurance company, or share suggestions about device usage that aren’t included in the labeling with physicians.

The agency announced June 12 that it finalized two question-and-answer format guidance documents related to manufacturer communications. The first addresses...