Staar Surgical faces quality system violations related to its Visian ICL and MICL intraocular lenses; MTI Precision Products didn’t notify FDA after it recalled TM20 hand pieces due to sharp nose edges; an employee responsible for elastic band production at Dexta Corp. was unable to answer questions about his job. Eight quality-related warning letters were listed by FDA from June 24 through July 7.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.
During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.
The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
The rallying cry to start as early as possible has become increasingly common in the world of medical device development. Innovation expert Dr. Stuart Grant challenges this conventional wisdom, asking: Is "sooner" truly better, or is there a smarter path to market for your medical device?
Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.
