USA – FDA draft guidance covers low-level light therapy devices
The US Food and Drug Administration (FDA) has published a draft guidance for low-level light therapy (LLLT) devices, or photobiomodulation (PBM) devices, which are...
USA – FDA drafts guidance on medical device voluntary improvement program
The US Food and Drug Administration (FDA) has issued draft guidance describing the agency’s participation in a permanent medical device Voluntary Improvement Program (VIP)...
USA – FDA launches TAP Pilot to speed access to safe and innovative medical...
The US Food and Drug Administration announced that it has launched a pilot program designed to foster earlier conversations in the medical device product...
USA – Guidance gives FDA authority to reject devices due to poor cybersecurity
While final guidance gives the US Food and Drug Administration (FDA) the authority to deny a new product application the product’s cybersecurity measures don’t...
USA – La FDA planche sur des directives relatives à la sécurité des objets...
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations...
USA – FDA rules on definitions of device; issues revised form for reporting adverse...
The US FDA has issued final guidance clarifying how the agency interprets existing references to section 201(h) of the FD&C Act and how the agency intends...
USA – The biggest misconception regulatory professionals have about the FDA 510(k) program, according...
The 510(k) program is the most common pathway through which medical devices make their way to market in the US.
For devices that can demonstrate...
FDA seek to harmonize human subject protections with revised Common Rule
The US Food and Drug Administration (FDA) on Tuesday issued two proposed rules aimed at harmonizing certain sections of the agency’s regulations on human...
USA – Studies linking recalled 510(k) devices to problematic predicate products are ‘warning shot’...
Two recent studies that link the recall of 510(k)-cleared medical devices to problematic predicate products should serve as a “shot across the bow” for...
USA – Mirvie’s Preeclampsia Test Designated an FDA Breakthrough Device
South San Francisco, Calif.-based Mirvie has secured the FDA’s Breakthrough Device designation for its test to indicate a woman’s risk of developing preeclampsia during...
