Re: Pray for me

Subject: Re: Pray for me
From: Annamaria Profit <inteltek -at- erols -dot- com>
To: Tim Altom <taltom -at- simplywritten -dot- com>
Date: Sun, 23 Jul 2000 18:30:05 -0400

There's one more wrinkle in this ASAP project..the FDA!! Maybe this
guidance will help you finesse their review?

> 2. FDA ISSUES GUIDANCE ON ANTICIPATING HUMAN FACTORS IN MEDICAL DEVICE USE
> The Food and Drug Administration ("FDA") released guidance on July 18
> that focuses on incorporating human factors engineering into risk management
> in order to reduce hazards related to use of medical devices. The guidance
> emphasizes the importance of identifying specific ways that people might use
> a medical device in order to identify significant device use problems in
> advance.
> To read the FDA's guidance, use our Ask Health Lawyers service at
> http://www.healthlawyers.org/askset.htm.
>

--
Annamaria Profit
E-mail: inteltek -at- erols -dot- com
URL:http://www.erols.com/inteltek


***************************************
"The world we have created today...
has problems which cannot be solved
by thinking the way we thought when
we created them."
...............................Albert Einstein




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