The Federal Communications Commission (FCC) regulates communications systems across the United States, but it also plays in manufacturing electronics. Electronics emit electromagnetic waves, which can interfere with other electronic products. The FCC regulates electronics to ensure these electromagnetic waves are safe.
How do electronics affect medical devices?
Medicine is moving more and more into the technological world, and with good reason. However, this also means there are many devices potentially affected by electromagnetic waves. These include:
- Pacemakers and defibrillators
- Cochlear implants and hearing aids
- Electronic pumps, shunts, and implants
- Smart devices, like Smart Contact Lenses
Some electronic devices cause electromagnetic disturbances, affecting other devices' function or performance in their proximity. This could be life-threatening for anyone wearing a device such as a programmable shunt, and painful for someone wearing hearing aids or Smart Contact Lenses.
What manufacturers of electronic products need to know
All electronic products oscillating at a frequency of 9kHz or higher, must be certified by the FCC. Products sent to the FCC for certification must be tested in an approved laboratory, and all the data gathered is stored in a public database.
There are two different processes that manufacturers may have to follow. Which process you’ll need to adhere to depends on whether your device is intended to transmit radio waves or whether the transmission is a by-product of the device’s functioning. ‘Intentional radiators’ are regulated through the Certification process. The FCC will approve the product based on test data and information submitted by the applicant. It is the applicant’s responsibility to arrange laboratory testing.
Unintentional radiators are regulated through the Supplier’s Declaration of Conformity (SDoc) process. Manufacturers can opt to apply through the Certification process instead. The SDoc process relies on manufacturers to ensure their product complies with regulations. The party responsible does not have to file for FCC regulation or have their test data added to a public database, but they must be US residents. However, a test report is still required.
Medical electronics are subject to similar regulations under the FCC. All electronic devices must state the user's level of risk in the instructions, especially where it may affect medical devices. This is true of medical devices themselves also.
Labeling and marketing
There is an extensive set of guidelines (PDF) regarding the labeling (PDF) of an electronic device.
At a glance, here are some of the rules for products regulated through SDoc:
- Each device must have a unique identification number. This is used to identify the device in the FCC’s compliance test records.
- End-users must receive a compliance statement containing the unique identification number, the full name and brand of the product, full contact details of the responsible party, and a statement that the product complies with FCC safety regulations.
- The compliance statement must be reasonably accessible to the end-user, such as within the manual.
Strict laws surround the promotion of radio frequency devices in the US. You cannot market your product without having FCC approval and following the label requirements. There are some exceptions.
The FCC logo
Any electronic product regulated successfully through the FCC may use the FCC logo to display its compliance with the regulations. However, this is optional and not legally necessary. You can include the logo within the instructions or e-label. The use of the logo represents official approval by the FCC and must not be used otherwise.
In conclusion, the FCC is a vital body in safeguarding the public from harm. It assures potential customers that your product is safe.