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The platform features inhaler sensors designed to automatically capture patient monitoring data, such as “when and how well patients use their medication,” Amiko said. Read More
Both guidances are applicable to all medical devices reviewed either through a 510(k) submission or a PMA application, and new details for combination products are included. Read More
At least three complaint cases evaluated by the FDA lacked the required root cause investigations or rationale for not initiating investigations. Read More