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Conventional Foley catheters and cutaneous electrodes are the first two types of devices to get their own final guidances under the FDA’s new safety and performance-based pathway for 510(k) marketing clearance. Read More
An FDA inspection of Harmonic Energetic Technologies’ Liverpool, New York facility revealed that the firm lacked numerous quality management systems. Read More
Validation failures, lax corrective and preventive action (CAPA) procedures, and failure to control product were just a few of the deficiencies uncovered during an FDA inspection of contract manufacturer Relucent Plastic Solutions in Erie, Colorado. Read More
Failure to implement procedures for reviewing and evaluating complaints, among other quality system lapses landed Peripheral Visions a Form 483 following an inspection of its Black Diamond, Washington facility. Read More
The FDA has cracked down on more companies trying to take advantage of the COVID-19 pandemic, issuing warning letters to four firms that sold unapproved COVID-19 tests online for use in patients’ homes. Read More
The European Commission’s Medical Device Coordination Group (MDCG) said notified bodies can make use of Medical Device Single Audit Program (MDSAP) reports for audits under the EU’s medical device and in vitro diagnostics regulations. Read More
In a move likely to send ripples through the supply chain, President Donald Trump signed an Aug. 7 executive order that directs the federal government to obtain medical countermeasures and essential components domestically and reduce reliance on foreign firms. Read More
Repackager and relabeler 180 Innovations failed to establish procedures for receiving, reviewing and evaluating complaints or for rework of nonconforming product, according to a Form 483 the firm received following an inspection of its Lakewood, Colorado plant. Read More
Failure to maintain and implement written medical device reporting procedures, complaint handling procedures and procedures for controlling nonconforming products were among the quality system failures uncovered during an FDA inspection of Neuromonics’ Westminster, Colorado facility. Read More