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?

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?

Frank, I haven't heard of this. I know that the TX Department of Heath Services is approved to perform inspections for the Mamography program (http://www.fda.gov/CDRH/MAMMOGRAPHY/accreditation.html).

This indicates the TX Dept of State Health Services does conduct audits under contract with the FDA.

Search | Contact Us | Internet Policy

--------------------------------------------------------------------------------
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.


DRUGS AND MEDICAL DEVICES DIVISION


About Us! | Links | Contact Us | Enforcement Actions


Device Distributors and Manufacturers


Medical Device Distributors and Manufacturers Rules

Answers consumer questions and provides information about the manufacturing and distributing of medical devices.
Enforces rules and regulations for medical device manufacturers and distributors.
Investigates complaints related to medical devices or refers complaints to the proper regulatory authority.
Conducts inspections of medical device manufacturers under contract with the U.S. Food and Drug Administration.
Responds to disasters to ensure that distressed medical devices do not enter or remain in commerce.
Conducts medical device health fraud investigations.
Licenses medical device manufacturers and distributors.

Return to top


Home | About Us! | Links | Contact Us | Comments

Send Comments and Suggestions to: WebAdmin.bfds@tdh.state.tx.us
This Page Last Updated on: Thursday, March 16, 2006