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Patient, Consumer Groups Press For More Oversight Of Device Iterations

Patient and consumer groups urged better FDA control over modifications to marketed products and expressed support for agency oversight of laboratory-developed tests at a recent update meeting on device user fee reauthorization.

Patient and consumer groups urged FDA to get a better handle on the performance of devices modified following an original approval or clearance, and they supported FDA oversight of laboratory developed tests during an Oct. 26 user fee reauthorization update meeting, according to meeting minutes

posted by FDA.

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