In addition to the rules in this subpart, medical testing experimental applicants and licensees must follow the rules in subparts B and C of this part. In case of any conflict between the rules set forth in this subpart and the rules set forth in subparts B and C of this part, the rules in this subpart shall govern.

(a) Eligibility for medical testing licenses is limited to health care facilities as defined in § 95.1103(b) of this chapter.

(b) Medical testing experimental radio licenses are for testing in clinical trials medical devices that use RF wireless technology for diagnosis, treatment, or patient monitoring for the purposes of, but not limited to, assessing patient compatibility and usage issues, as well as operational, interference, and RF immunity issues. Medical testing is limited to testing equipment designed to comply with the rules in part 15, Radio Frequency Devices; part 18, Industrial, Scientific, and Medical Equipment; part 95, Personal Radio Services subpart H—Wireless Medical Telemetry Service; or part 95, subpart I—Medical Device Radiocommunication Service.

(c) Marketing of devices (as defined in § 2.803(a) of this chapter) is permitted under this license as provided in § 5.602.

(a) Licensees may operate in any frequency band, including those above 38.6 GHz, except for frequency bands exclusively allocated to the passive services (including the radio astronomy service). In addition, licensees may not use any frequency or frequency band below 38.6 GHz that is listed in § 15.205(a) of this chapter.

(b) Exception: Licensees may use frequencies listed in § 15.205(a) of this chapter if the device under test is designed to comply with all applicable service rules in part 18, Industrial, Scientific, and Medical Equipment; part 95, Personal Radio Services subpart H—Wireless Medical Telemetry Service; or part 95, subpart I—Medical Device Radiocommunication Service.

Applications must specify, and the Commission will grant authorizations for, a geographic area that is inclusive of an institution's real-property facilities where the experimentation will be conducted and that is under the applicant's control. Applications also may specify, and the Commission will grant authorizations for, defined geographic areas beyond the institution's real-property facilities that will be included in clinical trials and monitored by the licensee. In general, operations will be permitted where the likelihood of harmful interference being caused to authorized services is minimal.

Medical testing licensees must file a yearly report detailing the activity that has been performed under the license. This report is to be filed electronically to the Commission's program experimental registration Web site and must, at a minimum, include:

(a) A list of each test performed and the testing period; and

(b) A Description of each test, including equipment tested; and

(c) The results of the test including any interference incidents and their resolution.

(a) Medical testing licensees must identify a single point of contact responsible for all experiments conducted under the license and must also identify a “stop buzzer” point of contact for all experiments, consistent with subpart E, §§ 5.307 and 5.308.

(b) Medical testing licensees must meet the notification and safety of the public requirements of subpart E, §§ 5.309 and 5.311.

Medical testing experimental licensees are exempt from complying with the station identification requirements of § 5.115.