Today, the FDA announced the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.
Commissioner Gottlieb mentioned in his statement earlier this morning the importance of ensuring that marketed medical devices have a positive benefit-risk profile, FDA having the right tools to quickly identify and address potential safety concerns, and fostering innovation of new products that are safer, more effective, and address unmet medical needs. Providing patients with access to safe medical devices that meet their health care needs remains a top FDA priority.
The Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health outlines how the agency will encourage innovation to improve safety, detect safety risks earlier, and keep doctors and patients better informed. In the plan, the FDA describes key actions it will take in the following areas:
• Establish a robust medical device patient safety net in the United States
• Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations
• Spur innovation towards safer medical devices
• Advance medical device cybersecurity
• Integrate the Center for Devices and Radiological Health’s (CDRH’s) premarket and postmarket offices and activities to advance the use of a TPLC approach to device safety
The FDA is modernizing measures to improve the safety of medical devices while continuing to create more efficient pathways to bring lifesaving devices to patients.
The FDA welcomes comments and feedback on this proposal and encourages other ideas and suggestions on how it can strengthen its regulatory programs. Input may be submitted through the public docket (FDA-2018-N-1315) at www.regulations.gov.
Download a PDF of the plan here.
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