As Innovation Expands, FDA Initiative Aims To Balance Progress, Patient Safety
April 25, 2018 | Risk Management News
Increasing medical-device safety while encouraging innovation is a core concern of the U.S. Food and Drug Administration's (FDA) recently announced Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. FDA approved a record number of novel devices in 2017, including the first artificial pancreas and the first blood test to evaluate traumatic brain injury, according to an April 17, 2018, statement from the agency's commissioner. Balancing the need for increased innovation with that of increased medical device safety is a top concern for FDA, the commissioner says.