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).

Return to top of page.

Return to HOC homepage.

Search Web Site

Henry Ott Consultants
48 Baker Road Livingston, NJ 07039
Phone: 973-992-1793, FAX: 973-533-1442

May 21, 2009