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The FDA has warned Masimo’s Irvine, Calif., facility over complaint issues, failure to establish and maintain procedures for implementing corrective and preventive action, and failure to investigate the causes of nonconformities. Read More
Devicemakers in the EU need to make sure they have at least two or three employees who are prepared to handle an audit, as notified bodies begin conducting the unannounced audits required by the European Commission. Read More
Manufacturers implementing unique device identification may choose a barcode for their Automatic Identification Data Capture technology, or they can use “any other technology that serves the same objectives,” new FDA guidance clarifies. Read More
The study shows FFR-guided PCI reduces rates of death, myocardial infarction and urgent revascularization in patients with stable heart disease. Read More
Devicemakers in the EU need to make sure they have at least two or three employees who are prepared to handle an audit, as notified bodies begin conducting unannounced audits required by the European Commission. Read More
Traditional methods for training new employees may be failing devicemakers, as most Form 483 observations can be traced back to training deficiencies, several experts say. Read More
The number of 510(k) submissions found not substantially equivalent could rise following recent FDA guidance blocking the use of split predicates and establishing expectations for benefit-risk determinations, say legal experts. Read More
Devicemakers should be prepared to justify their test methodology in 510(k) submissions for highly multiplexed microbiological/medical countermeasure in vitro nucleic acid-based diagnostics, or HMMDs, newly finalized FDA guidance says. Read More