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FDA Blacklists Third-Party Reviewer For Lying To Sponsors, Agency

The US FDA has yanked accreditation for a third-party 510(k) reviewer for lying about employing a reviewer and forging their signature. The company is also accused of lying about correspondences with the agency.

Black rubber duck left behind by yellow rubber ducks

The US Food and Drug Administration has pulled accreditation for the third-party reviewer Accelerated Device Approval Services (ADAS) because the agency says the company lied to a sponsor about a nonexistent reviewer and its communications with regulators.

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