The US FDA has created a web page with answers to common questions concerning the agency’s final rule on regulating laboratory developed tests as medical devices.
Since the Food and Drug Administration published its final rule in April on regulating laboratory developed tests (LDTs), the agency has been swamped with questions about how it plans to move forward and what the new regulations mean for industry and patients.
In response, the FDA has created a webpage based on the “most common questions” it has received related to...
To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.
Amendment brings new benefits for device accessories and aesthetic devices used by healthcare professionals.
