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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. Need copies of Fo...

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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. Need copies of Fo...

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https://loosecannon.name

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. Need copies of Fo...

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Misclassified Class III Devices

http://www.loosecannon.name/files/Misclassified.html

Open Letter to Manufacturers of Class III Devices. If your company makes one or more medical devices which the FDA has classified as Class III, you should ask the question: does each of my devices belong in Class III? 160; Unless you are certain your devices belong in Class III, you may find it worthwhile to pay close attention to what follows in this letter. A Simple Test to See if a Device Was Misclassified. 1) Is the device life-sustaining or life-supporting? 160; (Yes or No}. 160; (Yes or No).

2

Neurological Devices Panel Feb 2012

http://www.loosecannon.name/files/CES2012.html

February 10, 2012. I heard that some petitions to reclassify a medical device would be discussed at the Neurological Devices Panel meeting scheduled for February 10, 2012. The device to be discussed was the Cranial Electrotherapy Stimulator, or CES for short. Although I had no real interest in CES devices, I wanted to observe how the Panel and CDRH would interact concerning petitions to reclassify. I decided to attend the meeting, intending only to listen and observe. Mid-afternoon, a CDRH biomedical e...

3

Petition Response

http://www.loosecannon.name/Petition-Response.html

FDA GRANTS MY CITIZEN PETITION. A letter from CDRH dated March 4, 2013, contains the response to my Citizen Petition FDA-2012-P-0747 which called for an investigation into whether Form FDA 3429 Classification Questionnaire conformed to the definition of Class III in the law. The agency granted my petition, and acknowledged that changes in the Form were needed to more closely align the form with the law. While I was pleased that my petition was granted, there is no cause to celebrate. In my opinion (as a ...

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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. Need copies of Fo...

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A Loose Cannon | My life's trajectory isn't straight, and I'm OK with that.

My life's trajectory isn't straight, and I'm OK with that. You put your whole self in…. I obviously failed in my attempts to blog about training for a triathlon. I’m kind of OK with that. My brief stint in the triathlon world has taught me that triathletes LOVE TO TALK ABOUT TRAINING. That’s great for them, but. Hardly interested in how my running fluctuates from week to week (I look at Strava summaries sometimes), so I can’t imagine that anyone else would be. Not being terrified of the swim. How oft...