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117 results found for: fda
This article deals with the FDA risk classification continued evaluation of the potential risk of hazardous chemical exposure when utilizing dialysis devices. The FDA has issued a letter to health care providers to assess the risk of exposure to non-dioxin-like […]
Bans on Medical Devices by FDA A medical device ban is a complete restriction on all present and future production, distribution, and sales of medical devices if the FDA Medical Device Regulations believes that a medical device intended for human […]
This article deals with mandatory reporters like manufacturers, importers, device user facilities and voluntary reporters who each submit medical device 510k reporting to the FDA. Medical device reports are a post market monitoring method used to track the functionality of […]
IntroductionThis article deals with the FDA is informing health care providers about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, which include the Trifecta Valve and the Trifecta Valve with Glide Technology (Trifecta GT), which […]
This article is about public health emergencies when a medical device is used to manage or prevent an emergency. These consist of diagnostic testing equipment and materials, personal protective equipment such as gloves or masks and surgical instruments. Extra medical […]
This article deals with the Guidelines on the Food and Drug Administration’s Regulatory Actions during Declared National or State Public Health Emergencies which are being implemented. The FDA is the authorized agent for Medical Device registration in Philippines. This ensures […]
This Article Deals about FDA Registration for Diagnostic Kits. The approved SARS-CoV-2 molecular diagnostics was published on February 21, 2023 by the Food and Drug Administration, USA. These EUAs have been granted with specific authorization requirements for the manufacturer and accredited […]
The Saudi Food and Drug Authority (SFDA), Saudi Arabia’s Medical Device Regulator has pushed the enforcement of the Unique Device Identification by a year in phases. The SFDA bought in these regulations on 1st October, 2020. The new dates are […]
Eisai.Co.Ltd and Biogen has announced that lecanemabs is an investigational anti-amyloid protofibril antibody for treatment of AD(Alzheimer’s Disease) and the US FDA has granted Fast Track designation for it. Earlier FDA had granted Breakthrough Therapy designation for lecanemabs in June,2021. […]
The US FDA has Authorized Merck’s Covid-19 pill for high risk adults after a similar pill by Pfizer was given a green light to rollout. Merck’s Covid -19 pill authorization provides an additional treatment option against the covid-19 virus which […]