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The FDA has issued a draft guidance explaining how it defines and distinguishes “counterfeit” devices from the genuine article, as part of its implementation of the Safeguarding Therapeutics Act enacted Jan. 5. Read More
The FDA is looking to regularize the status of devices it has authorized for emergency use during the COVID-19 pandemic and has released two draft guidances — one explaining the transition away from emergency status and another on how the agency’s approach to enforcement will change for the affected devices. Read More
Citing the COVID-19 pandemic and other obstacles, the European Union has pushed back the dates by which manufacturers must comply with the EU’s IVD Medical Devices Regulation (IVDR). Read More
The European Commission has issued a regulation that will allow devicemakers to distribute instructions for use (IFUs) in electronic format, playing catch-up with the FDA and other international regulatory agencies that have already allowed devices to be accompanied by electronic-only instead of paper instructions. Read More
Sponsors of devices already cleared through the FDA’s 510(k) pathway that wish to gain approval for changing the sterilization method they use may find it easier to do so under a new pilot program the agency is considering. Read More
Dental Technologies of Lincolnwood, Ill., drew an FDA warning letter for not adequately investigating a manufacturing problem, among other quality violations. Read More
Sponsors of device trials in the EU that need to make significant changes to their study protocols can consult a new guidance document just released by the European Commission’s Medical Devices Coordination Group (MDCG) — written to support procedures for device trials as they relate to the EU’s Medical Device Regulation. Read More
DeVilbiss Healthcare failed to report a complaint of an injury to a patient using its DeVilbiss 525DS oxygen concentrator to the FDA within the required 30 days, the agency said in a warning letter to the company. Read More
The FDA would gain new authority to compel device manufacturers to comply with record requests under a bipartisan bill introduced in the Senate Tuesday by Sens. Bill Cassidy (R-La.) and Tammy Baldwin (D-Wis.). Read More
The Health Industry Distributors Association (HIDA) is calling for a “fast-pass” system to expedite movement of medical supplies, including personal protective equipment, through the U.S. transportation system. Read More