FDA Human Factors Guidance Revealed

A draft of FDA human factors guidance has been published. It discusses methods for integrating human factors into product development, sample size requirements for usability testing, and comparison with IEC 62366-1. We will discuss these topics in detail to understand their implications for product development and design. Read on for more information!

Draft FDA Human Factors Guidance

The FDA recently released the Draft Human Factors Guidance (HFG) for medical devices and combination products. This document outlines the current expectations of the agency for HF testing, clinical considerations, usability engineering, and user error. It is essential for manufacturers of medical devices and combination products because of the possible public health risks associated with user error. The guidance will also assist manufacturers in their premarket submissions and HFE/UE-related processes.

The Draft FDA human factors guidance for combination products includes examples of simulated and actual usability studies. In addition, the guidance states that …

How can you find out the gender of your child?

Finding out the gender of your child is something most parents dream about. It is often a big question and one that is answered after the birth. In some cases, you can find out the gender at the 20-week ultrasound, but this is not always the case. The doctor will look at any physical abnormalities and not at the gender. Sometimes this does happen, but it is not always the case. Fortunately, there is a solution because you can easily find out the gender of your child with a DNA test. Of course, you do not immediately start using a DNA test and there is a big chance that you will want to know more about it. Do you want to know more about a DNA test for gender? And what a fertility test exactly is? In this article, we will go into detail, so you can find out …

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On top of what outlines as protections in the Inexpensive Care Act, there are protections and rights that immediately assist people who identify as LGBTQ. In 2014, LGBT HealthLink …

Understanding Assertiveness

What it means to be assertive

People can often confuse being assertive with being over confident or even being somewhat aggressive, but this is not the case.  Being assertive simply means that you are able to express yourself and make it clearly understood what you want and what your boundaries are in a confident, nonaggressive and respectful manner.   

The ability to assert yourself is a useful social skill to have, as not being able to communicate your opinions, thoughts or needs can cause you problems at work, in relationships and friendships, as well as in daily life and all manner of social settings.

People who are assertive are more likely to stand up for themselves and are less likely to be the victim of bullies or suffer with stress, anxiety or depression.  They are also able to take constructive or negative criticism as easily as they can

Cluster of parechovirus infections found in Tennessee newborns

A cluster of 23 infants in Tennessee were diagnosed with a potentially severe childhood virus within a six-week span this spring — an unusually short amount of time for such a large number of cases, doctors reported Thursday.

The infants, ages 5 days to 3 months old, were infected with a type of parechovirus, according to a report published by the Centers for Disease Control and Prevention. This type of virus is not uncommon in children, but in babies younger than 6 months, it can be particularly dangerous, causing fevers, seizures and brain inflammation.

All of the infants developed a complication called parechovirus meningoencephalitis — an inflammation of the brain and brain lining — and were treated at Monroe Carell Jr. Children’s Hospital in Nashville. All but one were eventually admitted to the hospital.

The CDC’s report comes several weeks after the agency issued a nationwide health alert about