Draft Guidance for New Safer Technologies Program
In September 2019, the U.S. Food and Drug Administration (FDA) issued a draft guidance: Safer Technologies Program for Medical Devices.
As described in the Medical Device Safety Action Plan, the FDA is introducing the Safer Technologies Program to help spur the innovation of safer medical devices and more effective technologies that help address unmet health care needs and provide patients with timely access to safe, effective and high-quality medical devices.
Once the guidance is finalized, the Safer Technologies Program will be a new voluntary pathway, available for certain medical devices and device-led combination products that, through innovative designs, have the potential to significantly improve the safety of currently available treatments or diagnostics for diseases or conditions that are less serious than devices eligible for the Breakthrough Devices Program, but the use of which may be associated with serious or life-threatening risks.
The FDA believes the Safer Technologies Program will help patients have more timely access to safe and effective medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval (PMA), De Novo marketing authorization, and 510(k) clearance.
Submit comments to www.regulations.gov using docket number FDA-2019-D-4048 by November 18, 2019.
Upcoming Webinar on the Safer Technologies Program Draft Guidance
On November 6, 2019, the FDA will host a webinar on the Safer Technologies Program for industry and others interested in learning more about the Program and draft guidance. Registration is not necessary.
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