lunes, 23 de marzo de 2015

Reminder: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Final Guidance webinar

On March 12th, the FDA published a final guidance on reprocessing reusable medical devices. This guidance is a step toward further reducing the risk of patient infection by providing manufacturers with recommendations to validate their reprocessing instructions to ensure devices remain safe and effective for reuse.

We will discuss this final guidance document at a webinar scheduled on Tuesday March 24, 2015. The webinar is intended to help manufacturers understand the recommendations described in this final guidance document.  

Following a brief presentation, the FDA will respond to manufacturer’s questions regarding this guidance document.

Webinar details:
Registration is not necessary.
Date: Tuesday March 24, 2015
Time: 1:00 PM-2:30 PM, Eastern Time (please connect by 12:45 PM)

To hear the presentation and ask questions:
Dial: 888-324-3908; passcode: 7495402 | International: 1-312-470-7226; passcode: 7495402

To view the slide presentation during the webinar, you may use either link below:

We added an additional link to ensure that every participant is able to log in to the webinar. If you receive an error message while using the first link, please use the following link to obtain access to the live presentation:

Following the webinar, a transcript, recording and slides will be available at: The slide presentation will be available at this site on the morning of the webinar.
If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at, 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health

No hay comentarios: