FDA Report to C63

1
FDA Report to C63 SC84 May 2011

• Jeffrey L. Silberberg
• FDA/CDRH

2
FDA EMC Activities

• IEC 60601-1-2 Edition 4 CD2 and responses to
  comments on CD1
• C63.18 review
• Wireless coexistence
• Teleconference 2011-01-27 Steve Berger
• Teleconference 2011-02-17 Don Witters
• Working with University of Oklahoma - Tulsa

3
FDA EMC Activities (contd)

• Finalization of FDA wireless medical device
  guidance expected very soon.
• RFID
• Testing interaction with medical devices
• Working with the Association for Automatic
  Identification and Mobility (AIM Global) RFID
  Experts Group (REG) to develop test protocols for
  interference between RFID and medical devices