FDA Issues First Device 'Close-Out' Letter; Experts Weigh In On Details
• By Shawn M. Schmitt
THE FIRST QUALITY-RELATED DEVICE 'CLOSE-OUT' LETTER was sent by FDA to manufacturer Z-Medica on March 1, officially closing out a December 2009 warning letter that cited the firm for four violations of the Quality System Regulation. Z-Medica's close-out letter came surprisingly fast, given initial expectations from CDRH's Office of Compliance that close-outs could take up to a year. How quickly future close-out letters are issued depends on the specific violations and whether a follow-up inspection is needed, said Larry Spears, deputy director of regulatory affairs in the compliance office. Attorneys debate whether Z-Medica deserved the close-out letter and whether the contents were sufficient. Z-Medica explains how it fixed its quality problems and gained resolution with FDA in less than five months
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.
Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul
Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.
The medtech M&A landscape is experiencing a resurgence fueled by significant capital from private equity and venture firms, says Alex Wakefield, CRO of AcuityMD. Building strong relationships with physicians remains crucial in medtech, and defining an exit strategy early is imperative.