USA – Medical Device Development Tools (MDDT)
The FDA is announcing the qualification of a new tool through the Medical Device Development Tools (MDDT) program, marking the first-ever qualified database under...
USA – FDA proposes animal study requirements for dental bone grafts
The US Food and Drug Administration (FDA) on Thursday issued draft guidance for sponsors of dental bone grafting devices that offers advice on using...
USA – Device makers ask FDA for clarification, exceptions to metallic coating guidance
Medical device makers are asking the US Food and Drug Administration (FDA) to make exceptions to its recently proposed guidance on metallic and calcium...
USA – FDA Proposes New Ban of Electrical Stimulation Devices for Self-Injurious or Aggressive...
Today, the U.S. Food and Drug Administration (FDA) is proposing a ban of electrical stimulation devices (ESDs) intended to reduce or stop self-injurious or...
USA – FDA panel’s green light on glaucoma wearable device offers hope in sight
On 21 March, an advisory panel to the U.S. Food and Drug Administration gave its unanimous blessing to a piece of wearable technology that...
USA – FDA wants sponsors to test devices that may cause tissue temperature changes
The US Food and Drug Administration (FDA) wants medical device sponsors to test products that may cause changes in tissue temperatures, regardless of whether...
USA – FDA warns consumers against using plastic syringes made in China
It’s not unusual for the US Food and Drug Administration (FDA) to publish warning letters about manufacturers that fail to meet its regulatory requirements,...
USA – EPA finalizes rule to reduce EtO emissions from sterilization facilities
After a year of back and forth with the medtech industry, the US Environmental Protection Agency (EPA) has finally published a much-anticipated rule that...
USA – FDA proposes updates to device cybersecurity guidance
The US Food and Drug Administration (FDA) has released a draft guidance that proposes updating the agency’s final guidance on cybersecurity of medical devices. The update...
USA – FDA official discusses use cases, limits for device PCCPs
While predetermined change control plans (PCCPs) may not typically be appropriate for changes to a device’s indications for use, they can be useful for...
