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Devicemakers are urging the Centers for Medicare & Medicaid Services to maintain the current exemption on reporting financial support for continuing medical education programs under the Physician Payment Sunshine Act, a policy threatened by a proposed rule. Read More
With FDA investigators soon to begin scrutinizing UDI compliance, Class III devicemakers should prepare by ensuring that UDI changes in design history files are adequately documented and that the company has a verification process for barcodes in place. Read More
Devicemakers are asking the FDA to retain the current classification scheme for Class III devices, saying a proposal to establish risk-based categories would require PMAs for many more devices than currently undergo full premarket approval. 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
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