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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
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
Many devicemakers are ignoring opportunities to use new technology to service patients throughout the healthcare experience, a new report by PricewaterhouseCoopers warns. Read More
St. Jude Medical said Tuesday that it has resolved good manufacturing practice issues that had plagued its Plano, Texas, neuromodulation facility, leading to a 2009 warning letter. Read More
The FDA has warned Vention Medical’s Barreal de Heredia, Costa Rica, facility over environmental controls, equipment upkeep and other quality issues. Read More
Medical devicemakers are rebutting IRS claims that a significant portion of the industry is failing to pay the new 2.3 percent medical device excise tax, resulting in tax collections that are 21 percent below expectations. Read More