CDRH's vision for medical device safety to protect patients and spur 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 Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, 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 Total Product Life Cycle (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.
For more information:
- Safer Technologies Program for Medical Devices - Draft Guidance - September 18, 2019
- FDA Commissioner's Statement on new steps to promote innovations in medical devices that help advance patient safety - December 18, 2018
- FDA Commissioner's Statement on Modernizing 510(k) Program
- FDA Has Taken Steps to Strengthen the 510(k) Program - November 26, 2018
- CDRH Medical Device Enforcement and Quality Report - November 21, 2018
- Read our Commissioner’s Statement about the plan
- Read our safety alerts Medical Device Safety
- Read about FDA’s role in National Evaluation System for health Technology (NEST)
- Read about FDA’s Digital Health activities
- Read about FDA’s Cybersecurity activities
- Read about CDRH Transparency: Total Product Life Cycle (TPLC) database
- Read our Commissioner's Statement for an Update on Postmarket Surveillence and Women's Health