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The FDA said it would explore whether it has the authority to issue “umbrella regulations” to identify devices that may require additional training or user education beyond the physician labeling currently required. Read More
The AERs included changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation, migration of the device, and allergy/hypersensitivity or immune-type reactions. Read More
In cases where the denial is specifically because of a facility’s noncompliance with GMPs, the agency will provide a “substantive summary” of the failures identified. Read More
Artificial intelligence built into the device gauges the patient’s reaction to the displayed memories and adjusts content on the screen to guide the patient’s emotions. Read More
A litany of major GMP deficiencies — ranging from inadequate document control procedures, CAPA, device acceptance procedures and procedures to control product — plagued GEM City Engineering and Manufacturing during a Feb. 21 to March 1 FDA inspection of its Dayton, Ohio facility. Read More
Failing to establish procedures to review and evaluate complaints as well as CAPA procedures landed Alliance Precision Plastics a six-item FDA Form 483 following a March 28 to 30 inspection of its Rochester, New York, facility. Read More
In 2017, the agency approved 66 devices through the premarket approval and humanitarian device exemption pathways but only 18 of those were indicated for use in a pediatric population. Read More
In preparation, the department analyzed supply chains for medical devices and clinical consumables to determine the proportion of products that are routinely imported. Read More