Quality and regulatory expert Eric Henry spoke to Medtech Insight about the impact of the changes between the draft and final versions of the US FDA’s SIMD/SAMD premarket guidance document.
The US Food and Drug Administration’s final guidance on Content of Premarket Submissions for Device Software Functions may not differ too much from its 2021 draft, but the small changes may have a large impact.
Eric Henry, senior quality and regulatory compliance advisor at King and Spalding, spoke to Medtech Insight about the differences between...
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
The US FDA's new draft guidance details the responsibilities of new owners of 510(k) clearances, including making timely updates device listings in FURLS and GUDID to maintain accurate information for safety alerts and recalls. Comments on the draft are accepted until 4 August.
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.
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.
