Manufacturers are overlooking various key elements that should be included in device history records, including up-to-date labels, dates of product manufacture and missing signatures on documents, FDA says. Because DHRs touch virtually every part of a firm’s quality system, a flawed DHR can prompt agency investigators to dig deeper during inspections. Further, DHRs with absent signatures, test records or traceability records might cause investigators to doubt the validity of a manufacturer’s quality system. Experts also urge companies to make sure that device history records link to device master records, and they remind firms that DHRs are also tethered to production and process control requirements. Some manufacturers are in the beginning stages of implementing electronic device history records in an effort to curb mistakes and unnecessary costs.
Deficient device history records are a tell-tale sign for FDA that a manufacturer might not have adequate control over its quality system, according to an agency official and industry quality experts.
Device history records (DHRs) touch virtually every part of a firm’s quality system, so a flawed DHR can prompt agency...
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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.
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.
Market access concerns dominated at the annual BioWales In London event, where AstraZeneca set out industry’s priorities and the UK Office for Life Sciences struck an optimistic tone about how the UK will lastingly improve uptake of innovation.
