In 1976, Congress enacted the Medical Device Amendments (MDA). This law, now part of the Federal Food, Drug, and Cosmetic Act (FD&C Act), generally requires FDA clearance or approval before a new ...
The US Food and Drug Administration (FDA) has issued a new final guidance document intended to clarify the process by which manufacturers of "custom" medical devices can comply with federal ...
The pacemaker is a medical device that was initially introduced in 1958. At that time, the device used external components and was far from inconspicuous or convenient. Image Credit: Amphenol Sensors ...
The US Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the ...
WALTHAM, Mass.--(BUSINESS WIRE)--Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results