FDA Focuses On Human Factors To Help Minimize Device Recalls
This article was originally published in The Silver Sheet
Executive SummaryFDA PRESSES MANUFACTUERS ON DEVICE USABILITY: Although the words "human factors" don’t appear in the Quality System Regulation, FDA is spreading the word that usability must be factored in when firms manufacture devices. In fact, the regulation’s preamble – which carries legal weight – points out that user-friendly design is necessary. Nevertheless, some experts say not all companies are taking human factors into consideration and consequently are paying the price by removing their products from the marketplace and spending additional money to redesign devices from scratch
You may also be interested in...
According to the plaintiff, Unilever’s Pond’s Rejuveness Anti-Wrinkle Cream is defective insofar as tested product has been found to contain unlabeled mercury, constituting negligence that has resulted in user injuries. The plaintiff seeks certification of a transnational class and compensatory and punitive damages, among other relief.
HBW Product Launches: New Chapter Collagen, Alkamind Acid-Kicking, GNC China, Tetra Bio Canada, More
GNC, Harbin launch supplements in China following regulatory approval; Bee Gone expands with allergy swabs; Bed, Bath & Beyond expands distribution of CBDMedic personal care products promoted by Rob Gronkowski; Tetra Bio has Canadian OK For hemorrhoid and pain relief OTCs, US and European pending; Agrozen offers Urban Daze CBD products; New Chapter portfolio expansion also includes fermented vitamins, elderberry supplements and magnesium; and Alkamind’s Acid-Kicking Coffee Alkalizer creamers help neutralize acid from coffee.
In joint complaint, the FTC and New York Attorney General allege scheme to block generic Daraprim and maintain exorbitant list price; they cite hundreds of emails the incarcerated Shkreli has exchanged with co-defendant in last six months.