Postmarket Surveillance of Medical Devices CDRH's Number–One Priority — Are You Prepared?

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According to the FDA’s Center for Devices and Radiological Health (CDRH), postmarket issues are quickly becoming the center’s number–one priority — taking precedence over premarket matters.

Consider this …

For the first time ever, devices that have significant use in pediatric populations are now required to meet postmarket surveillance requirements.

And the amount of surveillance you may be required to conduct could increase significantly. Previously, the law only permitted 36 months of postmarket surveillance if the FDA and a manufacturer were in agreement. Now, the FDA can order 36 months without mutual agreement — PLUS it can order more than 36 months if it feels there is a necessity to further assess safety and efficacy.

And with a new automated tracking system in place, the FDA is ready, willing and able to embarrass you into fulfilling commitments by conducting random checks.

What does all this mean to you?

And what happens if you’re not in compliance?

How can you be certain your postmarket surveillance program is ready to face this new scrutiny?

Here’s how …

Attorney Elaine Tseng will show you the most effective way to meet the requirements of the FDA for postmarket surveillance. You’ll come away from this 90-minute Encore presentation fully prepared for the new postmarket surveillance program that is the result of the FDA Amendments Act (FDAAA).

Sign up your entire team to listen in and discover:

  • The nuts and bolts of the FDA’s postmarket surveillance authority under the FDAAA
  • How postmarket surveillance compares with postapproval studies
  • When and how postmarket surveillance can be imposed
  • Three pitfalls to avoid when preparing for postmarket surveillance
  • Strategies for meeting regulatory expectations for complying with postmarket surveillance requirements
  • 10 critical details to include in a postmarket surveillance plan
  • The role of postmarket surveillance in the bigger picture of the FDA’s Postmarket Transformation Initiative
  • Potential consequences of noncompliance
  • Four ways postmarket surveillance impacts other key FDA compliance requirements

Avoid warning letters or worse, product recalls!

This presentation is a must for positions in the medical device industry, including:

  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Data management and statistics personnel
  • Engineering and design controls team
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • QA/QC personnel
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Strategic planning and business development staff
  • Study monitors
  • Study research coordinators
  • Study sponsors
  • Training personnel
  • Validation specialists, scientists and engineers

Elaine Tseng is of counsel with King & Spalding’s FDA/Healthcare group. After prior practice with the group as an associate and partner-elect, Elaine rejoined the group following service as regulatory counsel at the FDA, where she received the Department of Health and Human Services Secretary’s Award for Distinguished Service and other FDA honors. In her practice, Elaine advises medical device, pharmaceutical and biotechnology companies on a variety of FDA approval, compliance and enforcement matters.

Register now!

Date: Aug. 4–22, 2008
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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