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This guidance document provides the FDA’s recommendations on performance criteria to support premarket submissions for endosseous dental implants and abutments in the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for endosseous dental implants and abutments will have the option to use the performa..

There are currently 53 devices enrolled in the FDA’s TAP Pilot.On October 1, 2024, the Total Product Life Cycle Advisory Program (TAP) Pilot expanded to include medical devices reviewed by the Division of Ophthalmic Devices (DHT1A) and the Office of Radiological Health (OHT8).The TAP Pilot is now accepting enrollment requests for Breakthrough Designated devices reviewed by the:Division of Ophtha..

Today, the U.S. Food and Drug Administration expanded the indications of the Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the management of type 1 diabetes in individuals two years and older, to also include management of type 2 diabetes in individuals 18 years and older. An interoperable automated glycemic controller is software that au..

The FDA has been working with COVID-19 test developers seeking to pursue marketing authorization through the traditional premarket review pathways, which will allow these tests to continue to be used beyond the time allowed by emergency use authorization.  This page lists COVID-19 tests that have received traditional marketing authorization. See the Marketing Your Device page for more informatio..

Since graduating from medical school in 1978, I’ve seen medicine and healthcare change in unimaginable ways for the better. However, one of the most alarming changes is the recent decline in life expectancy in our country, largely due to the cumulative impact of common chronic diseases (CCDs), combined with excessive rates of suicide, drug overdose and gun violence, and, of course, COVID-19. How..

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) and Ed Margerrison, Ph.D., director of the Office of Science and Engineering Laboratories (OSEL), CDRH  Today, the FDA’s Center for Devices and Radiological Health (CDRH) is announcing a partnership with the Bill and Melinda Gates Foundation to create new analytical met..

SummaryOn July 16, 2024, the U.S. Food and Drug Administration (FDA) will host a webinar to discuss how in vitro diagnostic products (IVDs) are classified by the FDA.  If you have questions that you wish to submit for possible discussion during the webinar, please email CDRHWebinars@fda.hhs.gov. All questions must be received by June 28, 2024, to be considered for the discussion. Questions will ..

As artificial intelligence continues to evolve, we are seeing revolutionary opportunities to enhance health care, especially through machine learning. AI can be applied across the spectrum of health applications, including for the prevention, diagnosis, and treatment of a variety of medical conditions, as well as for a range of administrative tasks. Health products, including those that are medi..

Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together The U.S. Food and Drug Administration (FDA) issued "Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together," which outlines the agency's commitment and cross-center collaboration to protect public health while fostering responsible and ethical medical product..

In Vitro Diagnostic (IVD) devices are a critical component of healthcare, as they help users diagnose conditions and formulate an appropriate treatment plan for a patient. In some cases, they may also be used for care management for certain diseases. In the U.S., IVDs are regulated like other medical devices and divided into one of three classes, each with its own general expectations for a spec..