Postmarket Surveillance of Medical Devices CDRH's Number–One Priority — Are You Prepared?
Product Details
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:
- 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!