FDA said it will delay implementing a rule put forth last year that would have changed how it determines the intended use of a medical product.
Regulatory and Compliance
Comments from a recent AAMI meeting on revising ANSI/AAMI PB70:2012 “Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities” reveal what changes could be in store for the standard.
FDA gave MR-conditional labeling to two of Abbott's cardiac rhythm management (CRM) devices, a move that further boosts the company's ability to compete with its peers in the space.
FDA puts out a lot of information over the course of a year. Here’s what you absolutely need to know going into 2018.
An FDA advisory panel voted against recommending approval for Intrinsic Therapeutic's Barricaid prosthesis designed for partial annulus replacement in patients with herniated discs.
The five-state settlement closes litigation over Medtronic's controversial Infuse bone graft device.
The agency is the first in the world to provide a comprehensive technical framework to advise manufacturers creating medical products on 3-D printers.
A short seller argues that TransEnterix should have disclosed a prior relationship between the company and a surgeon at a Florida hospital that just so happened to be its first U.S. customer. The company disputes the claim, calling the sale an arm's length transaction with no related party transactions to report.
An Indiana company is the first to win permission from FDA to market a device for use in helping to reduce the symptoms of opioid withdrawal.
FDA is warning the public about the dangers of using injectable silicone that is falsely marketed as FDA-approved dermal fillers for cosmetic enhancement.