IT'IS FDA/FCC Submissions Support

The IT'IS Foundation provides services for product compliance certification and pre-certification when standard procedures cannot be applied or test houses do not have the knowledge and/or are not equipped for it. Routine evaluations that can be conducted by test houses are only conducted by the IT'IS Foundation under exceptional circumstances.

We guarantee high quality results and work closely with our clients to maximize acceptance of the results by regulatory agencies such as the U.S. Federal Communications Commission (FCC) and the U.S. Food and Drug Administration (FDA). The IT'IS Foundation has closely cooperated with FCC and FDA in the development of product standards for demonstrating safety or compliance testing.

Past Achievements

Past achievements in our certification and pre-certification services include:

Evaluation of wireless power transfer systems from leading industrial manufacturers, involving the development of a measurement methodology, the exposure assessment of people in the near field of the systems, and compliance with international exposure limits.
Evaluation of implants with respect to human safety during MRI scanning. The service included submission, presentation of the results to the FDA, and follow-up extensions to address all comments.
Assessment of wireless systems that are not covered by standards, e.g., body mounted devices or implanted transmitters.

Our Expertise

To ensure that we have first-hand knowledge of the latest developments in the relevant standards, the IT'IS Foundation greatly benefits from its active involvement in several standards committees, as well as its consultancy to various government agencies such as the World Health Organization (WHO, CH), the International Commission on Non-Ionizing Radiation Protection (ICNIRP, DE), ICES/TC95 (USA), the National Physical Laboratory (NPL, UK), the Federal Office for Radiation Protection (BfS, DE), the Food and Drug Administration (FDA, USA), and the Research Institute of Occupational Health (under RAMS, Russian Federation).

The IT'IS Foundation is equipped with advanced measurement equipment and numerical simulation infrastructure to carry out the necessary work. The facilities on site include:

A facility for dosimetric compliance testing shared with Schmid & Partner Engineering AG (SPEAG), which meets the requirements for dosimetric evaluations according to international standards. The equipment includes SPEAG equipment (DASY, iSAR and EASY) and Zurich Med Tech equipment (MITS 1.5, MITS 3.0 and MITS Gradient).
A semi-anechoic chamber (7 × 5 × 2.9 m (L × W × H)) with an integrated DASY5NEO system that can be utilized for all research activities involving dosimetric, near-field, and far-field evaluations, the optimization and synthesis of handheld devices, body-mounted transmitters, implants, desktop applications, micro-base, and pico-base station antennas, exposure setups, calibration procedures, EMI tests, MRI safety tests, compliance testing of implants, etc.
Two reverberation chambers (4 × 3 × 2.9 m and 3.7 × 2.2 × 2.7 m (L × W × H)). Both chambers are equipped with two mechanical stirrers and provide controlled and consistent environments for EM emissions and immunity testing, as well as shielding effectiveness and susceptibility testing of electromagnetic equipment.
Measurement equipment such as spectrum and network analyzers, signal and waveform generators, radiocommunication testers, amplifiers, power meters, oscilloscopes, electric and magnetic field probes, antennas and incubators.
Fast and powerful computer hardware that is continually being upgraded, including multi-core processing hardware.