Dual-Labelled Names to Transition to Sole Names by TGA
This article deals with the changes to the dual labelling period as of April 30, 2023, by TGA Australia. The labels, Product Information (PI), and Consumer Medicines Information (CMI) papers are now requesting dual labelling for multiple ingredient names used […]
Read MoreEvaluation of Automatic Class III De Novo
This article deals with the classification of medical devices under the De Novo Pathway. Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically […]
Read MoreFDA Guidelines for COVID-19 Related Medical Device Transition Plans.
The Center for Devices and Radiological Health (CDRH) of the FDA has released two final guidance documents to help with transition plans for medical devices that have received Emergency Use Authorizations (EUAs) or fall under specific enforcement guidelines to support […]
Read MoreTGA Australia New Powers can help decrease patients exposure to medicine shortages.
The Australian Registry of Therapeutic Goods (ARTG) has made measures to help patients deal with the consequences of medication shortages, including the temporary import or supply of an internationally licensed pharmaceutical in place of one that is in limited supply. […]
Read MoreFDA Risk Classification on toxic compound exposure while using dialysis devices
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 […]
Read MoreNMPA certifies third batch of medical equipment
This article discusses NMPA Certification the decision to implement unique identification of medical devices for some Class II medical devices in order to continue implementing the Regulations on the Supervision and Administration of Medical Devices, the Notice of the General […]
Read MoreBans on Medical Devices by FDA Medical Device Regulations
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 […]
Read MoreHow 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 […]
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