# 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 cons ervation 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 behal f 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 dev ice trade associations that might be interested in the rulemaking: AdvaMed, the Medical Device Manufacturers Association, and the Medical Imaging & Te chnology Alliance, a division of NEMA.

• DOE is considering efficiency standard levels that could probably only be met by switch mode power supplies (SMPSs). For me dical EPS manufacturers alreadyproducing SMPSs, increasing their efficiency should not significantly affect thei r 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 medica l device it powers. The medical device must meet certain FDA require ments, 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 regulat ory situation, since the medical device manufacturer would no longer have complete cont rol over the performanc e of the system, and the third-party EPS vendor may or may not know e nough about the medical device to assure its safety and effectiveness when powered by t he 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 medi cal device is modified to meet EPS standards, the manufacturer may be required to file modifi cation notifications with the FDA, depending on the nature of the change. FDA has issued guida nce 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

12 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 c oncern electrical noise is, and for which specific medical applications.

• Al Taylor or Phil Desjardins will provide Ari Reev es with the names of cont acts at the three trade associations mentioned.