By Gilreath & Associates There’s no such thing as perfect. But when it comes to your medical devices, you want them to come as close as possible. The U.S. Food and Drug Administration (FDA) announced in May 2019 its intention to end a program they call the “alternative summary reporting.” In the past and present, […]

Posted in Uncategorized | No Comments »

By Gilreath & Associates Most consumers know Johnson & Johnson for their baby-friendly bath soaps, but they’re also one of the largest makers of health care products in the world, including artificial hips. Over 10,000 hip surgery cases later, the company is settling for $1 billion to cover the cost of 6,000 defective Pinnacle hip […]

Posted in Uncategorized | No Comments »

By Gilreath & Associates For those who use medical devices, the Food and Drug Administration (FDA) rating system is crucial and can be life-changing. Whether or not the FDA approves a product can bring great relief or dash hopes. This begs the questions: What is the difference between FDA approved and FDA cleared? The gap […]

Posted in Uncategorized | No Comments »