Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 96 - BLOODBORNE PATHOGEN CONTROL › Section 96.302 - Device Registration

Current through Reg. 49, No. 28; July 12, 2024
(a) The
				Department of State Health Services (department) shall compile and maintain a
				list of needleless system devices and sharps devices with engineered sharps
				injury protection that are available in the commercial marketplace and
				registered with the department to assist governmental units to comply with this
				chapter.
(b) Each needleless system
				device or sharps device with engineered sharps injury protection that is the
				subject of the department's device registration application shall be in
				conformance with all applicable premarket notification or premarket approval
				requirements established by the U.S. Food and Drug Administration (FDA) unless
				otherwise exempted from such requirements.
(c) Each device manufacturer who manufactures
				a needleless system device or sharps device with engineered sharps injury
				protection and who desires to register the device for the first time with the
				department shall apply for registration in accordance with the procedures found
				in §
									96.303 of
				this title (relating to Registration Procedures).
(d) If a device manufacturer introduces more
				than one needleless system device or sharps device with engineered sharps
				injury protection into commerce, the manufacturer shall register each device
				separately in order for the device to be included on a list maintained by the
				department.
(e) Each sharps device
				with engineered sharps injury protection that is the subject of the
				department's device registration application shall contain physical attributes
				consistent with those recognized as effective for engineered sharps injury
				protection, as defined in §
									96.101(9)
				of this title (relating to Definitions).
(f) The department may accept reports from
				authorities in other jurisdictions, including the FDA, to determine the extent
				of compliance with these sections and with the provisions of Health and Safety
				Code, Chapter 81, Subchapter H.
(g)
				The department shall register a needleless system device or sharps device with
				engineered sharps injury protection that meets the requirements of these
				sections.
(h) Registration of a
				needleless system device or sharps device with engineered sharps injury
				protection by the department does not constitute an endorsement or
				recommendation of such device.
(i)
				Registration certificates shall not be transferable from one device to another
				or from one device name to another. Any request for transfer of registration
				due to a change in ownership shall be made pursuant to the requirements in
				subsection (l) of this section.
(j)
				All device registration certificates shall expire two years from the date of
				issuance.
(k) Renewal of
				registration.
(1) Upon expiration of a device
				registration, the registration may be renewed by filing an application for
				renewal on a form prescribed by the department, accompanied by the appropriate
				renewal fee.
(2) The renewal
				registration certificate shall be valid for two years.
(3) 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
				system devices and sharps devices with engineered sharps injury
				protection.
(4) The department
				shall renew the registration of a needleless system device or sharps device
				with engineered sharps injury protection following receipt of the appropriate
				renewal form and renewal fee.