For nearly two decades, the Association for the Advancement of Medical Instrumentation’s (AAMI) human factors standard, HE 48, has been the only existing medical device user interface design standard.

With increased emphasis by global regulatory agencies on eliminating and controlling use error in devices, a new human factors standard with more direct relationship to healthcare contexts has been developed by the AAMI Human Factors Standards Committee. In this article, Pat Patterson and Robert North offer a preview into the new standard and how it applies to manufacturers.

Read the article: http://www.mddionline.com/article/sneak-preview-fdas-human-factors-standard

This week, the FDA introduced FDA Basics, a web resource intended to answer questions from consumers and patients as well as to discuss other important public health topics in a useful and user-friendly format.

Structurally, FDA Basics consists of the following sections:

• FDA Fundamentals
• Animal & Veterinary
• Cosmetics & Color Additives
• Dietary Supplements
• Drugs
• Food
• Medical Devices
• Radiation-Emitting Products
• Tobacco Products
• Vaccines, Blood, and Biologics

Visit http://www.fda.gov/AboutFDA/Basics/default.htm for more info.

According to an announcement issued this month, the FDA may now issue a Warning Letter “close-out letter” once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter. The FDA may issue a close-out letter when, based on evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

This is a great incentive for manufacturers to quickly address and remediate their warning letter findings.