US Rep. DeLauro Reintroduces Device Safety Bill To Remove PMA Product Liability Suit Protections
A US House representative and two co-sponsors have reintroduced the Medical Device Safety Act, which would remove the defense against state product liability suits for premarket-approved devices from the Federal Food, Drug, and Cosmetic Act (FDCA).
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2020 Outlook: US Congress Will Address Surprise Billing, Ratify USMCA, Conduct More Medtech Safety Oversight
Congress was able to approve a permanent medical device tax repeal and pass a “LAB Act” bill favorable to the diagnostic industry in 2019. But what device-related legislation is ahead in 2020? Medtech Insight takes a look at some of the medtech bills and draft legislation likely to affect manufacturers pending in late 2019 that are likely to be reviewed – and perhaps approved – in 2020.
Johnson & Johnson subsidiary Mentor Worldwide won’t have to face lawsuits filed by women who say they were injured by the company’s MemoryGel silicone breast implants. A California federal court ruled that FDA preemption blocked the suits.
With increased pressure on US FDA surrounding its approach to safety and growing concerns with Bayer's Essure birth control device, the agency is now requiring the manufacturer to extend a mandated post-market study of women who have been implanted with the product, among other requirements.