A medical device is an umbrella term for any instrument, software, or other article used alone or in combination for a medical purpose in humans. An estimated 2 million different kinds of medical ...

Tucked away in the Federal Register are the FDA's intentions to test its own labeling format to "inform FDA's planned regulatory approach to standardizing medical device labeling across the United ...

PORTSMOUTH, N.H., May 22, 2019 /PRNewswire/ -- Loftware, Inc., the global leader in Enterprise Labeling and Artwork Management Solutions, today announced the availability of Loftware Spectrum for ...

Under the FDA's newly enacted UDI rule, devices must be shipped with a unique identification label. (Click to expand.)--Courtesy of the FDA The FDA originally proposed requiring implantable medical ...

Overview: This webinar will provide valuable assistance and guidance to device companies in involved in labeling changes. FDA recently released a final rule regarding the parameters in which a device ...

Food and Drug Administration, HHS. The Food and Drug Administration (FDA) is proposing to implement provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to require electronic ...

FDA has published and makes available ALL regulations required for medical device companies. Look them up by searching 21 CFR part 820. And for outside U.S., you can easily obtain ISO 13485 for a ...

Unlike your doctor under Obamacare, if you like your medical device, you can probably keep it. But getting new devices to market through the Food and Drug Administration's regulatory gauntlet isn't ...

As of August, over 30 medical devices were approved by the US FDA alone, in 2019. Given recent technological advances and the increasing complexity of such products, the need for proper medical device ...

Microtest Laboratories has issued a management brief that discusses reusable medical device cleaning validation and testing practices in view of the FDA’s own discussions and actions around ...