How to Report Medical Device Issues by FDA
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 […]
Read MoreAbbott Trifecta Valves Potential Risk of Early Valve Degeneration by FDA
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 […]
Read MoreRegistration Requirements for Medical Gas System by MDA
This article deals with the Medical Gas System Guidance Document. The Medical Device Authority (MDA) created this Guidance Document to support the industry and healthcare professionals in their efforts to comply with the Medical Device Act (Act 737) and its […]
Read MoreReports of SCC in the Capsule Around Breast Implants
This article deals with the reports of squamous cell carcinoma in the capsule around breast implants released by the U.S. Food and Drug Administration (FDA) on March 8, 2023. The Food and Drug Administration stated that occurrences of squamous cell carcinoma […]
Read MorePublic Consultation on a Medical Device Cybersecurity Labeling System
This article deals with the public consultation for the cybersecurity labeling scheme for medical devices. Medical equipment is increasingly being linked to hospital and home networks in order to improve patient care. However, this connectivity expands the attack surface for […]
Read MoreVietnam Medical Device Registration to Address the Medical Supply
This Article deals with the new Decree Released by the Vietnam Medical Device Registration on March 4, 2023. The Deputy Prime Minister Tran Hong Ha signed Decree No. 07/2023/ND-CP. This amendment’s goal is to correct flaws, restrictions, and limitations that […]
Read MoreConditions of Emergency (Medical Devices) : FDA Registration
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 […]
Read MoreThe Breakthrough Devices Program Guidelines
This Article deals with the Updates for the Breakthrough Devices Program Guidance reducing Disparities in Health and Health Care. The FDA which is an authorized agent for Registrations in the country has developed a draft guideline to suggest minor updates […]
Read MoreNew Guidelines Implemented by the Philippines FDA
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 […]
Read MoreFDA Registration – SARS-CoV-2 Molecular Diagnostic Tests
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 […]
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