OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov.

May 12, 1997

Mr. Ken Shadoff
Quality Management Department
Canon USA, Inc.
One Canon Plaza
Lake Success, New York 11042-1198


Dear Mr. Shadoff:

This letter is in response to your request of November 7, 1996 for an interpretation of the electrical standards in 29 CFR 1910.303 through .399, Subpart S, and the application to electrically-powered medical devices. Your request was forwarded to the Office of General Industry Compliance Assistance of the Occupational Safety and Health Administration (OSHA) by Mr. John McFee of the Philadelphia Regional Office. We apologize for the delay in responding.

The scope of Subpart S, as specified in §1910.302(a), covers electrical installations and utilization equipment installed or used within buildings, as well as conductors that connect the installations to a supply of electricity. When used in the workplace, electrically powered medical devices are considered utilization equipment covered by Part 1910, Subpart S.

The definition of "acceptable" in §1910.399 states that an installation or equipment is acceptable [to OSHA] and approved within the meaning of Subpart S, if it is accepted, certified, listed, labeled, or otherwise determined to be safe by a nationally recognized testing laboratory (NRTL). When a NRTL accepts, certifies, lists, labels or determines electrically powered medical devices to be safe, option (ii) under the 1910.399 definition of "acceptable" may not be used.

The Food and Drug Administration's (FDA's) requirement to obtain market clearance for medical devices is unrelated to OSHA's requirements. FDA's jurisdiction is limited to testing the safety and efficacy of medical devices with regard to the manner in which these devices are used (i.e., medical safety of patients). OSHA's jurisdiction, on the other hand, concerns protecting the employees (e.g., physicians, nurses, medical technicians) who use the devices. Typically, the FDA evaluates the extent to which the devices meet the purported treatment objectives in a manner that does not endanger the patient, while OSHA is responsible through NRTL testing for ensuring that electrical conductors and equipment are electrically safe for use by employees in the workplace.

Additionally, the FDA regulates the manufacturers of medical devices, while OSHA regulates the employers. It is the employer who must ensure that the medical device meets the requirements of Subpart S.

If you have any questions, please call Helen Rogers at (202) 219-8031 x121.

Sincerely,



Raymond Donnelly, Director
Office of General Industry Compliance Assistance