Date: 4/22/2023
On April 17, 2024, the FDA released two reports detailing its progress on advancing medical device safety and innovation.
The reports, titled "CDRH 2024 Safety Report" and "CDRH 2024 Innovation Report," highlight the agency's efforts to ensure that medical devices on the U.S. market are safe, effective, and meet the needs of patients and providers.
The FDA has made significant progress in recent years, including:
Enhancing clinical trials and premarket review programs.
Creating new programs to support innovation, such as the Breakthrough Devices Program.
Improving medical device reporting programs and the recall process.
Partnering with patients to incorporate their voices into the agency's work.
The FDA acknowledges the challenges of regulating a vast and ever-changing medical device landscape. However, the agency remains committed to continuously advancing both safety and innovation.
This year, the FDA plans to take additional actions, including:
Reimagining the premarket review program.
Expanding its footprint in geographical innovation centers.
Launching a new program to extend high-quality healthcare into the home.
Expanding a program to assist companies in improving device quality.
Strengthening active surveillance of medical devices.
Enhancing the medical device recall process.
By taking these steps, the FDA aims to further its mission of protecting public health and ensuring that the agency is well-positioned to meet the evolving needs of the medical device industry.
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