Medical Devices

Automated External Defibrillators Final Order - February 5, 2015

Summary: On January 28, 2015, the FDA issued a final order that required manufacturers of automated external defibrillators to submit premarket approval applications (PMAs) in order to market their products. This action requires a more rigorous review of these devices, which will ultimately help improve their reliability. In addition, the FDA will also require premarket approval for critical AED accessories, such as batteries and pad electrodes.

On February 5, 2015, the FDA will hold a webinar for AED and accessory manufacturers. The webinar is intended to help manufacturers fully understand the final order, including clarifying the requirements and the timelines provided in the order. Following a brief presentation, the FDA will respond to manufacturer’s questions regarding all requirements of the final order.

Webinar Details:
Registration is not necessary

Date: February 5, 2015
Time: 2:30 – 4:00 PM, Eastern Time (please connect by 2:15 PM).

To hear the presentation and ask questions:
Dial: 800-369-1701; passcode: CDRH
International: 1-630-395-0030; passcode: CDRH

To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join.php?i=PW1335175&p=CDRH&t=c

Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will be available at this site on the morning of the webinar.

Note: The FDA is unable to provide Continuing Education Credits (CEU) or Certificates of Attendance for webinar attendance.

Target Audience: AED Manufacturers, AED Accessory Manufacturers, AED Industry Associations
 

Page Last Updated: 02/19/2015
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