25 Tex. Admin. Code § 96.302 - Device Registration
(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.
(l) 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 system devices and sharps
devices with engineered sharps injury protection in order to reflect the
change.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.