TX Department of State Health Services audits for the FDA related to medical devices

F

Frank34

#1
I have heard that the TX Department of Heath Services is now in the process of performing audits for the FDA related to medical devices on contract manufacturers and the Legal Manufacturers. They are applying the definition of 'Finished Devices' pretty heavily to what we contract manufacturers (and when I was working for a Legal Manufacturer) consider components. This then increases the scope of responsibilities and legal requirements substantially. However, due to the fact that the contract manufacturer does not get complaints (from the end user), has no control over the design, etc.. it will be rather difficult to meet all of the ‘requirements’ being imposed. Oh yea, there is of course a fee (% of revenue from what I hear) that will be due as well after registering with this state agency. Are there any others who have heard about this or are there similar situations in other states?
 
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F

Frank34

#2
Hope you dont mind if I reply to my own messgae but...
Also, if this stuff is going to be handled at the state level is there going to be variation in the interpretation and requirements per state?
 

Doug Tropf

Quite Involved in Discussions
#4
This indicates the TX Dept of State Health Services does conduct audits under contract with the FDA.

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The Texas Department of Health became part of the Department of State Health Services on September 1, 2004. For more information, visit www.dshs.state.tx.us.


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This Page Last Updated on: Thursday, March 16, 2006
 
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