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In a new procedural document released on Wednesday, the FDA directs its Office of Generic Drugs (OGD) to request additional data from sponsors of generic drug-device combination products if the generic product’s user interface is substantially different from the original product. Read More
The modular system is compatible with existing patient data consoles, surgical displays and endoscopes used in minimally invasive operating rooms. Read More
The FDA issued American Contract Systems a Form 483 that listed several deficiencies seen in previous inspections, including lax validations and “ineffective” corrective and preventive actions (CAPA). Read More
If the pump malfunctions, it could lead to organ dysfunction, a stroke or death, or it may require patients to undergo major surgery to replace the pump. Read More
The FDA handed Medical Chemical Corp. a Form 483 for not following its own written procedures after an inspection of the company’s Torrance, Calif., facility in March. Read More
The Association of Medical Device Reprocessors (AMDR) has issued an update on global regulatory standards for single-use medical device reprocessing and remanufacturing. Read More