FDA CDRH Medical Devices News

FDA Approves First Device for Pancreatic Cancer

The FDA has approved the first medical device specifically designed to treat pancreatic cancer. This approval marks a significant advancement in the treatment options available for patients diagnosed with this disease.

FDA CDRH Statements on Medical Device News and Regulatory Updates

The FDA's Center for Devices and Radiological Health (CDRH) provides a collection of statements and updates on medical device news and regulatory matters. This page serves as a repository for announcements, initiatives, and reports from CDRH, offering insights into their ongoing work and priorities.

FDA Lists Expiration Dates for At-Home COVID-19 Tests

The FDA has updated its list of authorized at-home COVID-19 diagnostic tests, including information on extended expiration dates. This guidance helps consumers and healthcare providers identify currently valid tests.

FDA Pilot for Medical Device Recall Communication

The FDA's Center for Devices and Radiological Health (CDRH) is launching a pilot program to improve the speed of communication regarding high-risk medical device recalls. This initiative focuses initially on specific device categories and aims to reduce the time between the FDA's awareness of a potential issue and public notification.

FDA Idea Lab for Home Health Medical Devices

The FDA has launched an Idea Lab as part of its Home as a Health Care Hub initiative to foster the development of new home health medical devices. The lab focuses on diabetes management as a test case, aiming to integrate devices for prevention, diagnosis, treatment, rehabilitation, and monitoring into patients' lifestyles.