Exposing the LASIK Scam

CDRH and postmarket surveillance
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Author:  Eye [ Sat Jul 07, 2007 6:08 pm ]
Post subject:  CDRH and postmarket surveillance

Susan Gardner is a PhD in the Office of Surveillance and Biometrics
This is how she explained what they do:

DR. GARDNER: Thank you. Good morning. Due to a small communication glitch, you're going to have to follow your hard copy if you'd like to see a copy of my slides. Or you can just watch me, whichever you prefer. But it's short, so.

I'm going to tell you about a major programmatic change in CDRH. And operationally, that is the move of the condition of approval study program from the Office of Device Evaluation to the Office of Surveillance and Biometrics. Briefly, the Office of Surveillance and Biometrics is involved both in the premarket and postmarket activities of the Center. We're involved in the premarket activities by virtue of the fact that the statisticians are in our office, and you hear from the statisticians at all your panel meetings. And also the epidemiologists are in our office, and you'll be hearing more from the epidemiologists as time goes on. We're also responsible for signal detection of adverse events by use of various monitoring tools, including the MDR system, the Medical Device Reporting System, and our MedSun program, which is the Medical Device Safety Network. We're responsible for analysis of the signals that we see, the characterization of product risk, and the coordination of Center response to major postmarket issues, including risk communication to the health care professionals. And we're also responsible for the interpretation of the MDR regulation.

The legislative authority for condition of approvals comes from 21 C.F.R. 814.82, and it says the post-approval requirements can include continuing evaluation and periodic reporting on the safety, effectiveness, and reliability of a device for its intended use. So that's our legislative basis.

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