Custom Devices

A. A custom device is one which is sometimes ordered from manufacturers by practitioners to conform to their own special needs or to those of their patients (i.e. prosthetic devices, dental devices and specially designed orthopedic footwear). B. Custom devices are exempt from performance standards or pre-market approval requirements; however, they are subject to FDA requirements for investigational use, banning, restriction of distribution, adulteration and misbranding. C. The exemption applied only to devices which are not generally available in finished form for dispensing, or on prescription, or for commercial distribution or generally available to other practitioners. [16.19.14.12 NMAC – Rp, 16.19.14.12 NMAC, 2/28/2023] 16.19.14.13 PROCEDURE FOR LICENSURE OF BUSINESS FOR MEDICAL GAS REPACKAGER OR SELLER AND FOR TRANSFER OF OWNERSHIP OF LICENSED BUSINESSES: A. An applicant shall submit required application and fee to the board. Applications for a license or license renewal under this section shall be made on a form furnished by the board. The board may require such information as it deems is reasonably necessary to carry out the purposes of this part. B. After preliminary approval of a new application for licensure, an applicant that is located in New Mexico shall submit a request for inspection and the inspection fee, where applicable, in advance of fourteen days of the requested date for inspection. All subsequent requests for inspection shall be submitted in advance of fourteen days of the requested date for inspection. C. The license provided for herein shall terminate upon the sale or transfer of ownership. Operation of a business subsequent to the date of such transfer or sale without a new application and approval by the board shall constitute a violation of the law under Subsection I of Section 61-11-14 NMSA 1978, and is subject to the penalties contained in the Pharmacy Act.