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This is a personal website, open to the public.  The purpose of this site is to share the experience and opinions of the site owner on a variety of subjects.  Most of the material relates to the regulation of medical devices by the Food and Drug Administration.

On the "FDA" page you will find a list of topics relating to the regulation of medical devices by the U. S. Food and Drug Administration.

On the "Law" page you will find a list of topics relating to personal experiences with the law.

On the "Bio" page you will find a brief biography.

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All material on this site is copyrighted.  Individuals may copy information for personal use only.

Copyright 2009-2012 Leroy L. Hamilton



     Last updated: May 12, 2014
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AN UNUSUAL INCIDENT
AT A CDRH ADVISORY COMMITTEE MEETING

CDRH runs a tight ship when it comes to advisory committee meetings.  See what didn't get reported when a visitor challenged the rules.  Click here.
BREAKING NEWS - MARCH 5

CDRH grants my Citizen Petition FDA-2012-P-0747.

Click here for details. 
Why won't CDRH answer a very basic question?
Class III is defined in the law.  I believe FDA has placed devices in Class III which do not meet the definition.  For more on this topic, click here.


May 21, 2013  FDA recommends that ILX devices be reclassified into Class II.  Orthopaedic and Rehabilitation Devices Panel agrees.  But there is plenty of bad news. More to the story.  Stay tuned.
December 2013.  I admit that I was mistaken about the logic diagram mistakes previously alleged.  Click to read the whole story. 

HELP!  I STILL need copies of Form FDA 3429 or the Classification Questionnaire which were used prior to February, 1997.  If you have a blank form or a completed form with an expiration date in the range 1976 to 1997, please let me know ASAP!  Please