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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must be made “in a manner that ensures the continued safety and effectiveness of the device,” the FDA emphasized in a draft guidance on predetermined change control plans (PCCPs) released Thursday.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
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
The FDA has approved the first over-the-counter (OTC) naloxone nasal spray — Emergent BioSolutions’ opioid overdose therapy Narcan, 4 mg — and is encouraging other producers to apply for OTC status. 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biocompatibility, provided the device is identical in composition to the reference product, the FDA said in a draft guidance released Tuesday.
An investigational artificial pancreas improved blood sugar levels in children age two to five with type 1 diabetes, researchers reported in TheNew England Journal of Medicine.
A postmarket study of a biometric chest patch and remote monitoring platform from Israel’s Biobeat Technologies showed a greater ability to identify patients with a high risk of health deterioration as compared to the standard National Early Warning Score (NEWS).