Ex Parte Meeting Report 

Date: February 2, 2011 

Time: 3:00-3:45 PM Eastern 

Location: Phone 

Organizer: Ari Reeves and Philip Desjardins 

Purpose: Get input from FDA on setting energy conservation standards for medical external 

power supplies (EPSs) 

Attendees 

Name Affiliation 

Alford Taylor U.S. Food and Drug Administration 

Philip Desjardins U.S. Food and Drug Administration 

Mary Brady U.S. Food and Drug Administration 

John Goldsmith U.S. Food and Drug Administration 

Victor Petrolati U.S. Department of Energy 

Ari Reeves D&R International, Ltd. on behalf of the U.S. Department of Energy 

Michael Vladimer Navigant Consulting, Inc. on behalf of the U.S. Department of Energy 

Meeting Summary 

• Per FDA’s recommendation, DOE will attempt to contact three medical device trade associations 

that might be interested in the rulemaking: AdvaMed, the Medical Device Manufacturers 

Association, and the Medical Imaging & Technology Alliance, a division of NEMA. 

• DOE is considering efficiency standard levels that could probably only be met by switch mode 

power supplies (SMPSs). For medical EPS manufacturers already producing SMPSs, increasing 

their efficiency should not significantly affect their cost. However, the costs of meeting efficiency 

standards would probably be much larger for manufacturers of linear power supplies. A relevant 

concern is that SMPSs typically generate more electrical noise than linear EPSs, and electrical 

noise may affect the performance of certain medical applications. FDA indicated that it would get 

back to DOE if it can identify any medical devices that would be affected by SMPSs. 

• Typically, a medical EPS is treated as part of, or component to, the medical device it powers. The 

medical device must meet certain FDA requirements, but generally the FDA has no standalone 

requirements for the EPS itself. An EPS that is sold separately is generally considered an 

accessory to the medical device with which it will be used. 

• An EPS that is sold by a third party (i.e., an entity other than the medical device manufacturer) 

would create a complex and uncertain regulatory situation, since the medical device 

manufacturer would no longer have complete control over the performance of the system, and 

the third-party EPS vendor may or may not know enough about the medical device to assure its 

safety and effectiveness when powered by the vendor's EPS. 

• Most of the medical EPSs DOE is considering regulating would likely be components of Class II 

medical devices. If the design of a Class II medical device is modified to meet EPS standards, 

the manufacturer may be required to file modification notifications with the FDA, depending on 

the nature of the change. FDA has issued guidance to help manufacturers determine under what 

circumstances a filing is required. 

• Many more medical devices are being used at home today than in the past. FDA's definition of 

home use has three parts: 

o Used outside a clinical environment, which is an environment where care is provided 

24x7 

o Requires adequate labeling for use 

 1 
 2 

o May require training by a trained health care provider for safe use 

Next Steps 

• Al Taylor will try to determine how much of a concern electrical noise is, and for which specific 

medical applications. 

• Al Taylor or Phil Desjardins will provide Ari Reeves with the names of contacts at the three trade 

associations mentioned.