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The FDA’s Special 510(k) application review can offer devicemakers the path of least resistance to market clearance, an official from the FDA’s Center for Devices and Radiological Health (CDRH) said, as long as the device meets specific criteria. Read More
Clare Medical of New Jersey reported in a recent study that its proprietary artificial intelligence (AI) tool that identifies elderly patients with a high probability of needing an emergency room (ER) visit or hospitalization within 30 days reduced these visits by 77 percent. Read More
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 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
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
Two separate lawsuits in the federal courts are claiming that Philips Respironics’ continuous positive airway pressure (CPAP) devices caused lung cancer, in one case leading to a death. Read More