Regulatory Compliance

The expectations for human factors engineering and usability studies for the medical devices are highlighted in the 2016 FDA guidance document to the industry. 

While the guidance is a broad document it highlights the framework for developing usability engineering programs appropriate for the medical devices. 

By assessing the complexity and risk profile of your product we can recommend human factors plans and studies that are tailored to your product profile.

Reduction of use errors for devices that contain drug products or assist in delivering medications is even more critical than the medical device alone. In addition to device usability topics the manufacturers must identify and mitigate any use errors related to dosing and treatment such as overdosing, underdosing, potential for dosing calculation errors and any events that could result in delay of treatment. 

FDA issued a final guidance for implementing risk-based approach human factors engineering for the combination products in 2023. While this and other related guidance documents are going through additional reviews and updates, the FDA expects the HF activities to be planned and executed throughout the product development cycle and results of all activities including final validation be submitted to the agency.

The FDA guidance and expectations for the manufacturers of drugs and biologics for understanding and mitigating the potential for use errors  are outlined in the draft guidance issues in 2019. The guidance clearly outlines the FDA expectations for submitting HF data as part of filing when appropriate.

We have extensive experience in assessing and identifying the complex drugs and biologics and developing tailored human factors plans for these programs. Simple programs may also need to be assessed and the rationale for limited or no human factors activities can be documented as part of the filings.