- TypeConference
- Location San Francisco, California, United States
- Date 21-11-2016
Education/Teaching/Training/Development
Manufacturing
Medical/Healthcare/Hospital
OVERVIEW
This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.
Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company.
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A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III.
Product Id : 500838
Instructor : David Dills
Monday, November 21, 2016 | 10:00 AM PDT | 01:00 PM EDT | Duration: 60 Minutes
AREAS COVERED IN THE SESSION
WHO WILL BENEFIT
For more details and updates please visit website
Compliance4All 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
+1-800-447-9407SI NO | Filename | Download |
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1 | How to Manage a Medical Device Recall | Download |