Henry Ott Consultants
Electromagnetic Compatibility Consulting and Training
FCC Part 15 Exemption for Medical Equipment
Question: I
am an EMC engineer from China, and I have a question with respect to
medical equipment and the FCC rules. According to FCC Part 15.103,
medical equipment is exempt from the FCC's technical standards. FCC
Part 15.103e lists the following exemption: "Specialized medical
devices (generally used at the direction of or under the supervision of
a licensed health care practioner) whether used in a patient's home or
a health care facility."
Since our company's main product is medical equipment, I want to know
if our products must comply with the FCC Part 15's technical standard.
I would assume that our equipment is exempt. is that correct?
Answer:
You are correct. In the United States medical equipment is exempt
from meeting the technical standards contained in the FCC
regulations, since medical equipment is regulated by the Food
and Drug Administration (FDA) not the FCC.
That, hovever, does
not mean that
your products are exempt from all EMC requirements. Your products must
comply with the FDA's EMC requlations.
In addition medical devices are still subject to the general conditions
of operation contained in FCC Sections 15.5 (non-interference
requirement) and 15.29 (inspection by the Commission).
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Henry Ott Consultants
48 Baker Road Livingston, NJ 07039
Phone: 973-992-1793, FAX: 973-533-1442
May 21, 2009