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    Drugs and Medical Devices Group is within the Division
    for Regulatory Services
    P. O. Box 149347
    Austin, TX 78714-3947
    512-834-6770


    Contact the Web Director


    External links to other sites are intended to be informational and do not have the endorsement of the Texas Department of State Health Services. These sites may not be accessible to people with disabilities.

Bloodborne Pathogen Control Program - Drugs and Medical Devices Group

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A list of registered needleless systems and sharps devices with engineered sharps injury protection is maintained by the Texas Department of State Health Services' (DSHS) Drugs and Medical Devices Group in order to assist state and local governments in implementing the bloodborne pathogen control provisions found in 25 Texas Administrative Code, Sections 96.101 - 96.601.

The devices included on this list are believed to be commercially available and as such shall have conformed to any applicable marketing clearance requirements established by the U.S. Food and Drug Administration and in effect at the time of their introduction into commerce. This list contains only those devices that are the subject of a registration application submitted to and reviewed by DSHS prior to inclusion on the list. Registration of a needleless system or a sharps device with engineered sharps injury protection is voluntary and does not constitute an endorsement or recommendation of such device by DSHS.


List of Registered Needleless Systems and Sharps Devices with Engineered Sharps Injury Protection.


If you are a manufacturer of a needleless system or a sharps device with engineered sharps injury protection and you would like your device to be included on the list, please complete the following registration form and submit with the appropriate registration fee to the Texas Department of State Health Services, P. O. Box 149200, Austin, Texas 78714-9200.

Bloodborne Pathogen Control Program- Device Registration Application    (PDF, 38KB)

  • The appropriate registration renewal form and renewal fee for each device should be submitted to the department not later than 30 days following the expiration date of the current device registration in order to maintain the device on the department's list of existing needleless systems and sharps devices with engineered sharps injury protection.
  • The device manufacturer shall notify the department in writing of any change that would render the information required in the initial registration application no longer accurate. Upon receipt of a written notification involving a change, the department may update the information contained in its list of needleless systems and sharps devices with engineered sharps injury protection.
  • If you have any questions or desire additional information concerning the application process, please contact the Licensing Group at (512) 834-6626

September 2000 Notice to Medical Device Manufacturers   (PDF 15KB)

This Site is updated regularly by DSHS. If you have any questions please e-mail WebAdmin.BFDS@dshs.state.tx.us

 

 

 

 

 

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Last updated March 16, 2011