Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health
FDA Requests Comments on Promoting the Use of More Modern Predicate Devices
On January 22, 2019, the U.S. Food and Drug Administration (FDA) issued the public notice and opened a docket for comments, "Modernizing the Food and Drug Administration's 510(k) Program."
The FDA is announcing the establishment of a public docket and a request for comments regarding FDA's proposal to consider making public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. As part of FDA's Medical Device Safety Action Plan, the Agency committed to strengthen and modernize the premarket notification (510(k)) program. The FDA is seeking public feedback on whether and how to make information about older predicate devices public, in order to promote the use of more modern predicates.
You may submit comments to the public docket at www.regulations.gov using docket number FDA-2018-N-4751 or by clicking the button below. Please submit comments for consideration by May 22, 2019.
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:
- 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