Goto Section: 5.401 | 5.403 | Table of Contents
Revised as of September 1, 2021
Goto Year:2020 |
§ 5.402 Eligibility and usage.
(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.
[ 78 FR 25162 , Apr. 29, 2013, as amended at 80 FR 52415 , Aug. 31, 2015]
Goto Section: 5.401 | 5.403
Goto Year: 2020 |
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