CDRH Terminating High-Risk Device Recalls Faster As Class I’s Increase In 2012
• By Shawn M. Schmitt
As the number of class I recalls climbed to a historic high in 2012, CDRH was already taking action to more quickly terminate such high-risk recalls. The device center beefed up its class I recall close-out process by developing a template to standardize terminations and ensure that recalls were appropriately addressed by manufacturers. “What we’re looking to do is to move beyond just removing the recalled device from the shelf,” CDRH official Ann Ferriter said. Officials at device firms Philips Medical Systems and Cordis sense that FDA has become more stringent, requiring nearly 100 percent of product pulled from the market before declaring a recall closed. Meanwhile, CDRH is tackling recall-related provisions outlined in the FDA Safety and Innovation Act, and an ex-FDA official explains why he believes the number of overall recalls jumped 9 percent in 2012.
FDA’s device center has significantly sped up the process for terminating class I product recalls at a time when the number of those high-risk corrections and removals continues to grow.
CDRH terminates a class I recall after it determines that a manufacturer’s corrective actions were sufficient to prevent a recurrence...
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.
The KINCISE 2 Surgical Automated System aims to “reduce the physical burden on surgeons compared to manual impaction in primary and revision hip and revision knee replacement procedures,” said J&J MedTech.
Quest reaffirmed its full-year guidance despite macroeconomic concerns and tariff uncertainty. Revenues are expected between $10.7bn and $10.85bn. Adjusted earnings per share (EPS) is estimated in the $9.55 to $9.80 range for the full year, with EPS between $8.62 and $8.87.
Allen Burton, Abbott’s medical director of neuromodulation told Medtech Insight that the delivery system was developed to make the procedure easier for physicians, especially those who perform the implantations infrequently.
