USA – FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies
Today, the U.S. Food and Drug Administration authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect...
USA – FDA criticized for approval of genetic test for opioid addiction risk
Physicians and public health advocates are urging the US Food and Drug Administration (FDA) to revoke its approval of AvertD to predict the potential...
UK – Regulation of devices in Northern Ireland
The Medicines and Healthcare products Regulatory Agency (MHRA) is the Competent Authority for medical devices and in vitro diagnostic (IVD) devices in Northern Ireland.
This...
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The US Food and Drug Administration (FDA) on Thursday issued draft guidance for sponsors of dental bone grafting devices that offers advice on using...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,...
