FDA Evaluates Contaminants, Including Metals, in Tampons Through Independent Literature Review
The U.S. Food and Drug Administration (FDA) has released findings from an independent review of …
The U.S. Food and Drug Administration (FDA) has released findings from an independent review of …
Medical devices are integral to modern healthcare, ranging from simple tools like bandages to ad…
A De Novo classification request provides a marketing pathway for novel medical devices for whic…
A PMA (Pre-Market Approval) Class III medical device represents the FDA's most stringent reg…
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to a…
The Quality System Regulation (QSR) , outlined in Title 21 of the Code of Federal Regulations (2…
The concept of substantial equivalent devices, often referred to as predicate devices, serves as…
An adverse event is any undesirable experience associated with the use of a medical product in…