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Conference Directory
Draft Guidance for Device Industry and FDA - Postmarket Surveillance
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Venue Name: Online Event
Country: United States of America
City: Palo Alto
State: california
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: Regulatory Affairs, Clinical Affairs, Postmarket Surveillance, Section 522, FDA Draft Guidance, Medical Device Industry, PMS 522, premarket approval application
Start Date of Conference:: 12-08-2011
End Date of Conference: 12-08-2011
Description of Conference: This webinar will cover FDA's Draft Guidance on Post market Surveillance Studies for device manufacturers Under Section 522. It will help you understand the proposed changes and agency expectations regarding different stages of Post market Surveillance Studies.
Why Should You Attend:
Postmarket surveillance under section 522 of the Federal Food, Drug, and Cosmetic Act (the act) is one means by which the Food and Drug Administration (FDA) can obtain additional safety and/or effectiveness data for a device after it has been cleared through the 510(K), PMA, HDE or PDP process.
Areas Covered in the Seminar:
- Review proposed changes
- Explain the legal background and overview of statutory criteria.
- Considerations regarding pediatric population provisions.
- Understand expectations for postmarket surveillance study duration.
- Describe the postmarket surveillance process and identification of issue.
- Why an order for postmarket surveillance will be issued under section 522?
- Learn why postmarket surveillance study plans are reviewed as an original submission and its amendments until the plan is approved?
- Determine the elements to Include in a Postmarket Surveillance Study Plan.
- Understand why FDA may order postmarket surveillance to address a wide variety of device-related public health questions?
- Current expectations for different stages of Postmarket Surveillance Study Reports.
- Why happens if you fail to complete a Postmarket Surveillance Study?
NOTE : Use this Promocode (128600)to avail 10% discount,Valid till December 30 & add another webinar to your shopping cart and get 20% off on its price
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Draft Guidance for Device Industry and FDA - Postmarket Surveillance
