On April 17, 2018, the Food and Drug Administration (FDA) released its Medical Device Safety Action Plan which outlines FDA’s intended steps to address medical device safety while preserving enough space for innovation in the market.
The FDA’s plan is the latest effort by the FDA on medical device safety, including a recent budget request seeking $70 million to create a Center of Excellence on Digital Health that would, among other things, craft new regulations for third-party certification for developing medical devices. This comes as FDA is pushing guidance and innovative approaches for oversight of digital health (see our blog).
According to FDA Commissioner Scott Gottlieb’s announcement, the FDA’s plan organized into five points that seek to balance patients’ timely access to devices and safety and effectiveness. Continue Reading FDA’s Medical Device Safety Action Plan