U.S. FDA Finalizes Medical Foods GuidanceSuzan Onel
g for Manufacturers FDA Releases Final Guidance on Medical Device Reporting for ManufacturersFDA Releases Final Guidance on Medical Device Reporting for ManufacturersAllison W. Shuren
The U.S. Food and Drug Administration ("FDA") has proposed updated guidance, intended to assist individuals in meeting the cybersecurity requirements for FDA medical device submissions. April 2024Alert On March 13, 2024, FDA released the draftPremarket Cybersecurity Guidance, proposing selec...
"This Note critiques the guidance document released by the Food and Drug Administration ("FDA") in connection with the medical mobile apps it intends to regulate and the regulations that govern medical mobile apps. Specifically, the main argument of this Note is that, while the document is clea...
The Food And Drug Administration has issued its final guidance for developers of medical apps and software used on mobile devices By Katie Wike,...
FDA issued this Guidance to provide general considerations to sponsors of clinical research to help them ensure the safety of trial participants, maintain compliance with good clinical practice (GCP) and minimize risks to trial integrity during the COVID-19 pandemic. G...
Medical Encyclopedia med·i·ca·tion (mĕd′ĭ-kā′shən) n. 1.A drug or other substance used to treat disease or injury; a medicine. 2.The act or process of treating a patient with medicine:the response to medication. American Heritage® Dictionary of the English Language, Fifth...
The FDA recently released guidance for manufacturers on design considerations for medical devices intended for use at home to address the unique...
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Guidance on Medical Device Tracking." This guidance is intended to provide guidelines to manufacturers and distributors about their responsibilities for medical device tracking under the Food, Drug and Cosmetic...
The draft guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, is a “cornerstone of our strategic priority of creating a national evaluation system for medical devices,” the FDA wrote in an email. “That system would build on and leverage ...