Q&A Guidance Clarifies Human Factors Testing For Combination Products

A highly anticipated final guidance from the FDA on Human Factor Studies answers frequently asked questions about human factor studies when designing combination products. 

A woman opens an auto injector by taking off the blue cap.
• Source: Shutterstock

More from Guidance

HIMSS 2025: Interview with Aneesh Chopra, Arcadia’s Chief Strategy Officer, About The Future Of Health Data, Interoperability, AI

 
• By 

Medtech Insight sat down with Arcadia's chief strategy officer Aneesh Chopra to discuss interoperability, industry standards and the future of health care data and AI.

Global Medtech Guidance Tracker: February 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 30 documents have been posted on the tracker since its last update.

AI Bias Page, Health Equity Discussion Paper Back On FDA Site

 

Two US FDA device center websites have been restored under a restraining order. The pages now carry a disclaimer alleging they include "extremely inaccurate" content about gender; however, neither site includes any substantive discussion of trans issues.

UK HTA Body NICE Promises Positive Shake-Up For Medtech Users

 
• By 

Medtechs watch with interest as NICE, a long-standing component of market access for innovative technologies in the National Health Service, vows to get to grips with technology programs that often miss the target for developers of groundbreaking solutions.

More from Compliance

New Deadlines Loom For Medtech And App Developers Under New EU AI Act

 

As the EU AI Act takes shape, critical details are emerging rapidly. However, the approaching deadlines are even more pressing. This article delves into the essential information that medtech professionals need to stay ahead.

Non-EU Medtech Firms May Face Suits Under New Product Liability Directive

 

The EU’s new Product Liability Directive will make it easier for European consumers to seek compensation relating to defective products even if manufacturers are based outside the bloc. Legal experts caution that this could have substantial implications for pharmaceutical companies.

NSAI Hopes To Reverse IVDR Suspension By Irish National Authority In March

 

The Irish notified body has had to suspend IVD client work since late 2024.