USA – FDA proposes guidance on orthopedic product coatings
The US Food and Drug Administration (FDA) wants orthopedic device sponsors to provide additional data in their premarket application if their product has a...
USA – FDA updates sterilization category to encourage vaporized hydrogen peroxide use
The US Food and Drug Administration (FDA) has recategorized vaporized hydrogen peroxide (VHP) as a sterilization agent, signaling to medical device manufacturers that it...
Canada – Amendments to the Medical Devices Regulations to address future public health emergencies
On February 22, 2023, the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use...
USA – FDA updates third party 510(k) guidance
The US Food and Drug Administration (FDA) has published a draft guidance that updates a 2020 final guidance on its third party 510(k) review...
USA – Experts discuss red flags that can trigger legal action against drug and...
Legal observers discussed some of the red flags that can trigger legal actions against healthcare product manufacturers, as well as some of the lessons...
USA – Fall unified agenda includes new rule on removing outdated regulations, returning QMSR...
The Department of Health and Human Services (HHS) recently published the fall 2023 unified agenda for the US Food and Drug Administration (FDA) that...
USA – Combination products: FDA experts address UDI, harmonization, OPQ reorganization
Officials from the US Food and Drug Administration (FDA) fielded wide-ranging questions on the development and marketing of combination products — from UDI requirements...
USA – Device cybersecurity must be a priority from design through retirement, experts say
Cybersecurity must be a priority for any medical device that connects to the internet, from its earliest design phase to the end of its...
USA – Combination products: Non-harmonized regulations are hurting manufacturers
Divergent global regulatory frameworks are making it tough for manufacturers to move ahead with innovative combination drug/device products, according to a panel of experts...
USA – TCET pathway may broaden access to breakthrough devices, but reforms still needed
While the Transitional Coverage for Emerging Technologies (TCET) pathway proposed by the Centers for Medicare and Medicaid Services (CMS) offers the potential to speed...
