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Manufacturers of diagnostics designated for research or investigational use only should limit their use to the earliest stages of device development, Alberto Gutierrez, director of CDRH’s Office of In Vitro Diagnostics and Radiological Health, said during a Wednesday webinar sponsored by the American Association for Clinical Chemistry. Read More
Devicemakers that make modest improvements to their products will, in most cases, not need to file a new 510(k), the FDA says in a report released to Congress on Tuesday. Read More
FDA advisors Wednesday urged the agency to rescind the OTC bronchodilator monograph for epinephrine and racepinephrine products delivered via a hand-held rubber bulb nebulizer, saying the combination products present safety concerns that only an NDA can address. Read More
Devicemakers planning a PMA or product development protocol should take advantage of presubmission determination meetings with the FDA to pin down exactly what data the agency expects to support safety and efficacy of a new product. Read More