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The FDA has published a unique device identification compliance guide aimed at helping small manufacturers prepare for UDI implementation, the first stage of which comes due in September. 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
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
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
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
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
Notified bodies should conduct unannounced audits of facilities that make Is/Im and in vitro diagnostic self-tests every two years if the product carries a high risk, is often noncompliant with EU regulations or otherwise raises concerns about manufacturing and quality deviations, Team-NB says in its updated industry conduct code. Read More
Industry is raising concerns about a new Turkish regulation that bans advertisements of certain medical devices and requires device sales centers to be government-certified and employ “qualified” persons. Read More
Companies filing premarket approval applications for companion diagnostics may explain the clinical significance and clinical cut-off of their products using a summary of the clinical results for the corresponding drug product, recent technical guidance from Japan’s Pharmaceuticals and Medical Devices Agency says. Read More
Manufacturers are all but blocked from using split predicates for 510(k) devices, under a newly finalized U.S. Food and Drug Administration guidance on substantial equivalence determinations. Read More