SECTION 118.31. Laser Hair Removal Facility--Responsibilities

(a) The LHR facility registrant must notify the department in writing of any changes that would render the information contained in the application for LHR registration or the certificate of LHR registration inaccurate.

(b) Notification is required within thirty (30) days of the following:

(1) change in business name of the LHR facility;

(2) change in physical location of the LHR facility;

(3) change in street address where LHR devices will be used;

(4) change in LSO;

(5) loss or change of the LHR facility's LHR professional; or

(6) loss or change of the LHR facility's consulting physician.

(c) The LHR facility registrant shall comply with the adverse reporting requirements for device user facilities in Title 21, CFR, Part 803 - Medical Device Reporting. Copies of all reports of adverse events submitted in accordance with Title 21, CFR, Part 803 shall be submitted to the department within 24 hours of their initial submission to the manufacturer, FDA or both as determined by the consulting physician in accordance with §118.60.

(d) If the LHR facility registrant loses the services of the consulting physician, the registrant may use another physician(s) who has been designated in the contract in accordance with §118.30. If the LHR facility registrant loses the services of both designated consulting physicians, the LHR facility registrant shall immediately cease LHR procedures until the LHR facility registrant establishes a contractual relationship with a consulting physician.

(e) Each registrant shall conduct a physical inventory of all LHR devices in its possession at an interval not to exceed 1 year. Records of the inventories shall be made and maintained in accordance with this chapter, and shall include:

(1) LHR device manufacturer's name;

(2) model and serial number of the LHR device;

(3) specific location of the LHR device (for example, room number);

(4) name, title, and signature of the person performing the inventory; and

(5) date the inventory was performed.

(f) Each registrant shall maintain records of receipt, transfer, and disposal for each LHR device in accordance with this chapter. The records shall include the following information:

(1) LHR manufacturer's name;

(2) model and serial number of the LHR device;

(3) date of the receipt, transfer, or disposal;

(4) name and address of person LHR devices were received from, transferred to, or disposed of with; and

(5) name of the individual recording the information.

(g) A LHR operator is responsible for maintaining the LHR facility's compliance with the requirements of the Act and this chapter.

(h) A LHR operator shall not claim, advertise, or distribute promotional materials that claim that laser hair removal is free from risk or provides any medical benefit.

(i) A LHR operator shall not produce false or misleading advertising regarding the services offered at the facility. An advertisement of services using lasers for hair removal shall be deemed to be false or misleading if it is inaccurate or misleading in any particular regarding representations made or suggested or failure to reveal material facts with respect to consequences which may result from the use of such services.

(j) When a LHR facility registrant decides to terminate all activities involving LHR devices authorized under the facility certificate of LHR registration, the registrant shall immediately:

(1) request termination of the facility certificate of LHR registration in writing; and

(2) submit to the department a record of the disposition of the LHR devices, and if transferred, to whom the devices were transferred.

(k) Each facility certificate of LHR registration issued in accordance with this chapter shall be subject to the applicable provisions of the Act and to the applicable rules and orders of the department.

(l) No certificate of LHR registration issued or granted under this chapter shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, to any person.

Source Note: The provisions of this §118.31 adopted to be effective November 1, 2017, 42 TexReg 4815