FDA Webinar for Automated External Defibrillator (AED) and AED Accessory Manufacturers- Final Order
Today, the FDA issued a final order that will require manufacturers of automated external defibrillators to submit premarket approval applications (PMAs) in order to market their products. This action will require 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.
The PMA process allows the FDA to:
- review quality systems and manufacturing information for these devices and accessories;
- conduct pre-approval inspections;
- review changes in manufacturing facilities where devices are made; and
- review design and manufacturing changes that affect safety and effectiveness to assure that the changes are adequately evaluated and tested prior to implementation.
The process will also require manufacturers to submit to the FDA any changes made to the devices that affect safety or effectiveness, and annual reports on device performance.
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.
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.
If you have any questions regarding the final order, please contact CDRH’s Division of Industry and Consumer Education (DICE) at email@example.com, 1-800-638-2041, or 301-796-7100.
If you have any questions regarding the webinar, please contact CDRH Learn.
Food and Drug Administration
Center for Devices and Radiological Health