Justification for consolidating similar systems
Certification applications should have specific test data for the 1.5 MHz channel mode at the supported Section 95.2363(b) frequencies, along with test data for other operating modes if supported by a device.
In addition, there should be multiple Form 731 line entries (one for each transmit mode) and grant conditions stating that there is a 1.5 MHz channel mode, to support frequency coordination if the spread spectrum mode causes frequency coordination issues. Other general information on medical telemetry devices can be found on the FCC webpage: Sharing of Analog and Digital Television Spectrum by Medical Telemetry Devices.
TCAM), and facilitates the convergence of conformity assessment practices in the regulatory sphere.
The REDCA interfaces with relevant organizations such as ETSI, ECC and ADCO RED.
Question: We have a biomedical telemetry device that operates using VHF and UHF television broadcast bands and we would like to certify it.
These changes may create interference to existing medical telemetry devices or result in harmful interference to authorized services, requiring alteration of the operating channel for some devices.
Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff Question: Will the FCC restrict us from certifying our device if it operates under multiple rule parts?
Answer: FCC Section 2.1033(e) permits certification of transmitting devices that are subject to multiple rule parts.
Simple saline solutions do not meet the above criteria.
Question: Does the EU have an organization to disseminate information on conformity assessment in the EU, similar to the TCBC and the FCC?
Search for justification for consolidating similar systems:
Answer: The EU has the REDCA (Radio Equipment Directive Compliance Association) for conformity assessment procedures, to ensure consistent application by all parties in order to achieve an open and competitive market throughout Europe.