In an attempt to bring clarity to its current experimental licensing rules and policies, and to expand the opportunities for manufacturers and research organizations to bring new products to the market expeditiously, the Federal Communications Commission (FCC) has created three new types of experimental licenses and has adopted new application processing procedures. To accomplish this, the FCC entirely rewrote Part 5 of its rules, and eliminated all service-specific experimental rules.
The FCC will continue to issue conventional experimental licenses for specific projects to be conducted over a specified period of time. In addition, three new types of experimental radio service (ERS) licenses will be available: (1) Program Licenses; (2) Compliance Testing Licenses; and (3) Medical Testing Licenses. The three new types of experimental licenses will be issued for five year terms and may be renewed. While there are specific eligibility standards for each of the new license types, the FCC will require applicants to demonstrate that it, or an entity with whom it intends to collaborate, has demonstrable expertise of working with radio frequency (RF) devices.
First, a Program License will be available for colleges, universities, research laboratories, medical research institutions, and manufacturers of radio frequency equipment or end-user products with integrated radio frequency equipment. Eligible applicants will be authorized to conduct long-term research programs without being required to return the the FCC for new authority for each individual experiment. Instead, the FCC will be creating a new database in which the applicant will provide data regarding the program (i.e., frequency, location, etc.), and the identification of a “stop buzzer” point of contact who will have the ability to immediately terminate operations if interference complaints are received. That information must be supplied at least 10 days prior to the commencement of each experiment. Subsequently, the licensee also must post reports to the on-line database within 30 days after each experiment, describing the results, and detailing any incidents of interference.
Next, the FCC created the Medical Testing License, which can be used to conduct clinical trials of new medical devices that integrate RF wireless technology or communications functions for diagnosis, treatment, or patient monitoring. This license is intended to be used for clinical testing of medical devices that have already gone through the initial development stage (i.e., utilizing a Program License or conventional experimental license) and now must be tested for patient compatibility and use in real-world situations. Because of the limited nature of this license, the FCC narrowed the scope of eligibility for these licenses to include only health care facilities, medical clinics, and public health facilities. As with the Program License, applicants must demonstrate that they have the expertise to conduct trials, or they may serve as a “test bed” for other manufacturers to run clinical trials at their locations. Devices tested under this licensing regime must comply with existing RF rules and frequency assignments specified in Parts 15, 18 and 95 of the FCC's rules, and must submit a yearly report to the FCC providing a description of the tests, the equipment tested, and detailing any incidents of interference.
Finally, a Compliance Testing License will be available for labs that conduct testing for FCC equipment authorizations. The applicants must be either an experienced RF testing labs or a lab that can demonstrate to the FCC that it has sufficient expertise to test RF devices. Since the equipment technical information will be detailed in the Equipment Authorization System, the FCC will not require the submission of separate reports in the ERS database, nor will it require the notification or designation of a stop buzzer point of contact.
The FCC also modified its rules governing licenses for market trials. Noting the value of real-world trials during the developmental stage, the FCC now will permit manufacturers in residential areas equipment that has yet to go through the authorization process so long as the trial is covered by an existing experimental license held by the manufacturer. The FCC will also permit the operation of such devices for demonstrations in trade shows, so long as the device operates at, or below, the maximum power level permitted in Part 15. To expedite the integration of new equipment by third parties, the FCC will permit the sale of evaluation kits containing unauthorized equipment, so long as the purchaser is made aware of the authorization status of the equipment.
Lastly, the FCC harmonized its rules for the importation of devices that have yet to go through the equipment authorization process. Previously, the FCC had different standards for devices that operated in a radio service requiring a separate license from the FCC, and those for other services. Two thousand units could be imported for services requiring a separate license, while only 200 units could be imported for services not requiring a separate license. The FCC received comments suggesting that an increase in this level would permit more comprehensive market trials of unauthorized equipment, and expedite the introduction of new services to the public. As such, the FCC modified its rules to permit the importation of 4000 units, regardless of the type of radio service.
Many of the new rules will become effective on May 29, 2013. Experimental licenses are filed on FCC Form 442. However, the new version of FCC Form 442 has yet to be approved, so some of the rules will not become effective until the form and the associated rules have been reviewed and approved by the Office of Management and Budget.
Please let us know if we can answer any questions or provide additional information regarding these new rules and procedures.