Request for Comment on Federal Contract HHSF223201210171C - Inspection of Medical Device Manufacturers


The Texas Department of State Health Services has an ongoing contract with the U.S. Food and Drug Administration.  A link to the contract is provided below.

DSHS solicits comments on this contract. We will accept comments throughout the year.

U.S. FDA Medical Device Contract

Funding provided by FDA under this contract allows theTexas Department of State Health Services to enhance its inspectioncapabilities associated with licensed medical device manufacturers, resultingin an increased number of inspections of these facilities.  Inspections ofmedical device manufacturers helps to minimize the potential for adulteratedand misbranded products to be introduced into commerce in Texas.  Fundingunder the contract also provides for basic and advanced training of stateinspectors in order to maintain adequate levels of proficiency required toaccomplish these complex inspections.  Additionally, the medicaldevice industry benefits from the regulatory guidance provided by stateinspectors during these inspections, thereby helping to ensure that Texasmanufacturers are operating in conformance with all applicable state andfederal requirements.      




Comments may be submitted to:

Megan Snyder, Manager
Drugsand Medical Devices Group MC 1987
TexasDepartment of State Health Services
P.O. Box149347
Austin,Texas 78714-9347

Phone:(512) 834-6755