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 the Texas Department of State Health Services to enhance its inspection capabilities associated with licensed medical device manufacturers, resulting in an increased number of inspections of these facilities. Inspections of medical device manufacturers help to minimize the potential for adulterated and misbranded products to be introduced into commerce in Texas. Funding under the contract also provides for basic and advanced training of state inspectors to maintain adequate proficiency levels required to accomplish these complex inspections. Additionally, the medical device industry benefits from the regulatory guidance provided by state inspectors during these inspections, thereby helping to ensure that Texas manufacturers are operating in conformance with all applicable state and federal requirements.
Link:
Comments
Comments may be submitted to:
Megan Snyder, Manager
Drugs and Medical Devices Group, MC 1987
Texas Department of State Health Services
P.O. Box 149347
Austin, Texas 78714-9347
Phone:512-834-6755
Email: megan.snyder@dshs.texas.gov