May 16, 2014 by Arezu Sarvestani
Covidien subsidiary Given Imaging landed a victory with FDA medical device regulators who agreed to downgrade the PillCam capsule endoscope to a lower-risk classification.
The FDA bumped PillCam down to a Class II device with establishment of special controls, lowering the bar for review of the device from the premarket approval pathway to the 510(k) premarket notification pathway. Given Imaging had submitted a petition for the downgrade in November 2012. Read more
May 15, 2014 by MassDevice
Looming sentry-like over the collection of artifacts that document FDA’s history, the products we regulate, and our interactions with the public is a rather large and curious figure. It is a green velvet head with bulbous, languid eyes and two upper teeth in an otherwise large and empty mouth. It doesn’t have ears or hair, but is marked by a few bright green pustules. This is part of a life-size costume, an element of a public education campaign called Fight Bac! in which FDA was a major participant. It began in the 1990s to alert the public, young and adult alike, to the dangers of food-borne diseases and how to avoid them.
Countless objects in our collection tell the decades-long tale of FDA’s educational activities. For example, the agency still has a cabinet and some of its contents from the “Chamber of Horrors” exhibit that traveled around the country in the early 1930s to alert citizens, legislators, the press and others of the need for a stronger consumer protection law, drawn from egregious examples of how the law then in place fell short. FDA officials also communicated through a variety of other displays for Congressional testimony and other purposes. Read more