FDAnews Device Daily Bulletin

FDA Warns Vidco for Validation, MDR, Complaint-Handling

July 5, 2017

The FDA warned device manufacturer Vidco over improper device validation, design verification and medical device reporting.

The agency issued a warning letter after a January inspection of the company’s Beaverton, Ore., facility. According to the FDA, a review of seven change notices for Vidco’s NetViewer MDP2040-0100 device found numerous discrepancies, including failure to document the results of validation of software changes or to update risk analyses.

Investigators also found two of the firm’s change notices did not document whether the design outputs met design objectives, and at least one other notice did not document performance requirements for the internal speaker added to the NetViewer device.

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