| (a) Any device manufacturer desiring to register a needleless system device or sharps device with engineered sharps injury protection shall make written application for registration on forms provided by the Department of State Health Services (department). A separate completed application is required for each device to be registered. Registration application forms may be obtained from the Department of State Health Services, 1100 West 49th Street, Austin, Texas, 78756. (b) The initial application for device registration shall include the following information: (1) name, model, common name, and available sizes of the device; (2) premarket notification or approval number assigned by the U.S. Food and Drug Administration, unless otherwise exempted; (3) name, mailing address, and telephone number of the device manufacturer; (4) name of the contact person for the device manufacturer; (5) designation as either a needleless system device or sharps device with engineered sharps injury protection; (6) if a sharps device with engineered sharps injury protection, a description of the physical attribute(s) that effectively reduces the risk of sharps injury; and (7) name and signature of the person responsible for submitting the device registration application. |
