USA – FDA revises magnetic resonance guidance to reflect updated international standard
The US Food and Drug Administration (FDA) has revised its position on magnetic resonance (MR) with updates to a pair of final guidance documents.
One...
USA – FDA proposes guidance on orthopedic product coatings
The US Food and Drug Administration (FDA) wants orthopedic device sponsors to provide additional data in their premarket application if their product has a...
USA – FDA updates third party 510(k) guidance
The US Food and Drug Administration (FDA) has published a draft guidance that updates a 2020 final guidance on its third party 510(k) review...
USA – FDA publishes final guidances on device shortage reporting, computational modeling
The US Food and Drug Administration (FDA) has published two final guidance documents for medical devices on the agency’s implementation of Section 506J of...
USA – FDA opens TAP
The US Food and Drug Administration (FDA) has initiated a soft launch of its Total Product Lifecycle Advisory Program (TAP), which was negotiated under...
USA – Experts discuss red flags that can trigger legal action against drug and...
Legal observers discussed some of the red flags that can trigger legal actions against healthcare product manufacturers, as well as some of the lessons...
USA – FDA final rule reduces radiological devices reporting requirements
The US Food and Drug Administration (FDA) on Thursday issued a final rule that significantly reduces record-keeping requirements for medical devices such as x-rays....
USA – FDA updates off-the-shelf software guidance to reflect least burdensome approach
The US Food and Drug Administration (FDA) has reissued a final guidance on off-the-shelf (OTS) software used by medical devices, which aims to reduce...
USA – Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological...
This guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of...
USA – New guidances outline eSTAR submission requirements for de novo and 510(k) device...
The US Food and Drug Administration is one step closer to requiring electronic submission of all premarket applications for both 510(k) and de novo...
