Thank you to everyone who came to the HFES Symposium and saw Melissa Lemke’s presentation on Threshold Analysis in Human Factor Validation Testing. This symposium has grown so much over the years and Agilis is honored to be a part of that growth. Given the considerable interest in our topic, we are making the presentation available for a limited time, see below for details.
No Human Factors Validation Needed -
How Threshold Analysis Can Be a Successful Alternative to Human Factors Validation Testing
FDA expects sponsors of medical devices and products that have the potential for serious harm to submit premarket evidence of safe and effective use and to show that risks to users are minimized as much as practicable. Human factors validation testing is intended to achieve these goals.
Agilis has had success in an alternative approach for certain cases that meet a threshold analysis. At a basic level, threshold analyses examine the differences in use-related risks between a new combination product and existing comparator product(s) (i.e., defined as products on the market with similar intended users, user interface elements, and user-device interactions).
What are the Risks?
Working under the assumption that FDA-approved comparators are both safe and effective for users, the results from a threshold analysis can provide evidence of safe and effective use by showing that the new or updated product presents no more use-related risk than existing products on the market. When presented in a convincing way (i.e., the sponsor shows that a new product poses no more risk than a FDA-approved comparator product), threshold analyses have been accepted by FDA in lieu of presenting HF validation testing data.
Agilis provides insight into how threshold analysis strategies may be utilized and how FDA may respond to the submission, including real-world, recent case studies.