FDA finalizes combination product guidance 7 years after sharing draft

Dive Brief:

The Food and Drug Administration has finalized its guidance on the application of human factors engineering principles to combination products.
Officials released a draft version of the guidance for consultation in 2016 but received pushback from AdvaMed. The medtech trade group called the overlapping human factor requirements of device and combination product guidance documents “overly burdensome.”
More than seven years later, the FDA has finalized the combination product guidance. The final text differs from the draft version, with the FDA switching to a question-and-answer format and rewriting almost all of the text.

Dive Insight:

Concerns about overlapping requirements between a 2011 FDA document about applying human factors engineering to medical devices and the 2016 draft guidance on combination product recommendations united the drug and device industries. PhRMA, the pharma equivalent to AdvaMed, called for clarity on what the draft added to the advice already provided in the 2011 device text.

Since closing the comment period in 2016, the FDA has worked to address the concerns. The result is a Q&A document designed to be used in conjunction with the FDA’s 2011 device guidance and another document titled “Safety Considerations for Product Design to Minimize Medication Errors.”

The Q&A repeatedly references the 2011 document, advising readers to rely on the device guidance for information about design considerations for formative studies, human factor definitions, use-related risk analysis and more. The Q&A adds definitions for “final finished combination product” and “combination product critical task,” but in other areas refers to the older document.

Instead of providing recommendations for formative studies and other activities, as the draft guidance did, the final text addresses questions that may come up as companies develop combination products. For example,it explains that a drug’s properties can affect how a user interacts with a combination product by causing pain that hinders the ability to administer an injection.

Other questions address how the FDA evaluates the results of human factor validation studies, principles to consider when modifying a combination product, and the information required to support the start of clinical trials.