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 audio CD/Transcript fully prepared for the new postmarket surveillance program that is the result of the FDA Amendments Act (FDAAA).
Order today to listen in and discover:
Avoid warning letters or worse, product recalls!
This audio CD/Transcript is a must for positions in the medical device industry, including:
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.
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