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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must be made “in a manner that ensures the continued safety and effectiveness of the device,” the FDA emphasized in a draft guidance on predetermined change control plans (PCCPs) released Thursday.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biocompatibility, provided the device is identical in composition to the reference product, the FDA said in a draft guidance released Tuesday.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.
Sponsors submitting a 510(k) application for certain soft contact lenses may demonstrate substantial equivalence to previous lenses instead of having to conduct a direct comparison to a prior device, the FDA said in a final guidance released yesterday.
In a pair of final guidances released Friday, the FDA laid out what it intends to do with multiple pandemic-era device policies and Emergency Use Authorizations (EUAs) when the public health emergency formally ends on May 11. Read More