Center for Devices and Radiological Health Archives

FDA Publishes Human Factors Guidance

February 5, 2016 By Eric Shaver Leave a Comment

On Wednesday, the Food and Drug Administration (FDA) published the long awaited Applying Human Factors and Usability Engineering to Medical Devices guidance document.

As noted in the Scope:

This guidance recommends that manufacturers follow human factors or usability engineering processes during the development of new medical devices, focusing specifically on the user interface, where the user interface includes all points of interaction between the product and the user(s) including elements such as displays, controls, packaging, product labels, instructions for use, etc. While following these processes can be beneficial for optimizing user interfaces in other respects (e.g., maximizing ease of use, efficiency, and user satisfaction), FDA is primarily concerned that devices are safe and effective for the intended users, uses, and use environments. The goal is to ensure that the device user interface has been designed such that use errors that occur during use of the device that could cause harm or degrade medical treatment are either eliminated or reduced to the extent possible. (pp. 1-2)

A more in-depth review will be posted in the coming weeks.

Human Factors is a CDRH Regulatory Science Priority for 2016

November 11, 2015 By Eric Shaver Leave a Comment

Last month the FDA’s Center for Devices and Radiological Health (CDRH) released their Top 10 Regulatory Science Priorities for 2016. As noted in their report:

“The CDRH regulatory science priorities serve to accelerate improving the safety, effectiveness, performance and quality of medical devices and radiation-emitting products, and to facilitate introducing innovative medical devices into the marketplace. It helps the Center address the most important regulatory science gaps or needs. These priorities will be reassessed and updated periodically to reflect current regulatory science needs.” (p. 5)

The list includes:

Leverage “Big Data” for regulatory decision making
Leverage evidence from clinical experience and employ evidence synthesis across multiple domains in regulatory decision making
Improve the quality and effectiveness of reprocessing reusable medical devices
Develop computational modeling technologies to support regulatory decision making
Enhance performance of Digital Health and medical device cybersecurity
Incorporate human factors engineering principles into device design.
Modernize biocompatibility / biological risk evaluation of device materials
Advance methods to predict clinical performance of medical devices and their materials
Advance the use of patient reported outcome measures (PROMs) in regulatory decision making
Collect and use patient experience/preference in regulatory decision making

Human Factors Guidance Listed in FDA 2015 Priorities

January 14, 2015 By Eric Shaver Leave a Comment

In 2011, the U.S. Food and Drug Administration (FDA) released their draft guidance Applying Human Factors and Usability Engineering to Optimize Medical Device Design.

It provides the FDA’s “current thinking on this topic” and the recommendations “…are intended to improve the usability of devices to reduce use error, injuries from medical devices, and product recalls. The FDA believes that these recommendations will help control current risks and reduce future risks associated with device use” (p. 4).

The draft guidance has generated a lot of interest – and provoked numerous questions – from the medical device community. At the 2013 International Symposium on Human Factors and Ergonomics in Health Care: Advancing the Cause, Ron Kaye, Human Factors Pre-Market Evaluation Team Leader for the FDA, noted that more than 500 comments were submitted to the Agency during the review period.

A recurring question since its release has been “When will the draft guidance be finalized?” It looks like we have our answer.

The FDA has released the CDRH Fiscal Year 2015 (FY2015) Proposed Guidance Development and Focused Retrospective Review of Final Guidance, which includes the draft guidance on their “A-list” (…prioritized device guidance documents that the Agency intends to publish within 12 months of the date this list is published…).

It will be interesting to see if the final guidance is substantially different or not from the draft guidance.