We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Illumina said it will appeal a Federal Trade Commission (FTC) order to divest itself of Grail — developer of the Galleri early detection liquid biopsy test to screen for multiple types of cancer. Read More
A bipartisan group of U.S. lawmakers has reintroduced proposed legislation to “modernize the review process for diagnostic testing” and clarify the regulatory authority between the FDA and the Centers for Medicare and Medicaid Services (CMS). Read More
Modifications needed to continually improve software functions for artificial intelligence (AI)-enabled medical devices must be made “in a manner that ensures the continued safety and effectiveness of the device,” the FDA emphasized in a draft guidance on predetermined change control plans (PCCPs) released Thursday. Read More
If the FDA is forced to go back to fiscal 2022 levels — as House Republicans are proposing — there will be fewer inspections and many new medical products won’t get approved, said FDA Commissioner Robert Califf during a fiscal 2024 budget hearing on Wednesday. Read More
A bipartisan group of members of the U.S. House of Representatives introduced a bill on Tuesday requiring Medicare to cover all devices that have an FDA Breakthrough Designation for four years while the FDA and the Centers for Medicare and Medicaid Services (CMS) make a final coverage determination. Read More
Starting March 29, new applications to the FDA for a “cyber device” must identify any vulnerabilities and include a plan for ongoing security throughout the device’s life, the FDA said in a final guidance released yesterday. Read More
When submitting a 510(k) application for non-spinal bone plates, screws and washers, sponsors may reference “previous testing experience or the literature” to demonstrate biocompatibility, provided the device is identical in composition to the reference product, the FDA said in a draft guidance released Tuesday.
Animal studies meant to support a medical device premarket approval application should be conducted using the device in its finished form, according to a final guidance the FDA issued yesterday.