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.
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.
More from Regulation
• By
A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.
• By
Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
• By
About 200 staff in the FDA’s Center for Devices and Radiological Health were among the 3,500 FDA employees let go in today’s staff reductions. The cuts, which one employee described as a “Manhattan Project” to the center, are already having a major effect on staff morale.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
More from Policy & Regulation
• By
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
• By
The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.