The FDA said yesterday that certain imported respirators (FFRs) may be eligible for emergency use authorization (EUA) to protect public health and safety during the coronavirus outbreak. The FDA said these these devices, imported from Australia, Brazil, Europe, Japan, Korea and Mexico, may be effective in protecting healthcare workers from airborne COVID-19 particulates, “based on […]
Australia suspends sales of certain textured breast implants
Australian health officials have suspended sales of some textured breast implants for six months and recalled models of those implants already distributed due to concerns about an uncommon form of lymphoma. The Australian Therapeutic Goods Administration (TGA) temporarily halted import, export and supply of eight models of breast implants following reports of about 100 cases […]
Australia delays new 3D-printed regulatory changes
Australia’s Therapeutic Goods Administration is pausing plans to implement new regulatory changes intended to manage devices and products produced through the use of additive manufacturing, according to a new report from the Regulatory Affairs Professionals Society. The decision to delay the regulatory changes came after the agency received a number of comments asking for clarifications, […]
New Zealand’s Medsafe regulatory body removes pelvic mesh products from market
New Zealand’s regulatory body Medsafe has taken steps to remove a number of surgical mesh products from the country, according to a release posted today. The agency said the product’s removal was the outcome of a recent regulatory action on surgical mesh products, specifically those designed for treating pelvic organ prolapse via transvaginal implantation and […]
Australia mulls green-lighting overseas-approved devices
Australia’s Therapeutic Goods Administration this week proposed to allow the marketing of medical devices that already won approval in certain other jurisdictions. Under the proposal, devices approved by authorities in countries that are part of the International Medical Device Regulators Forum would be allowed onto the TGA’s Register of Therapeutic Goods. In addition to Australia […]
Australian regulators to take GI Dynamics EndoBarrier off the market
GI Dynamics (ASX:GID) said it received notice from the Australian Therapeutic Goods Administration that it’s pulling the EndoBarrier device off the market Down Under effective Oct. 12. The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract to treat Type II diabetes and obesity. GI […]
Diabetes: New warnings for Medtronic’s Paradigm insulin pumps
Australian healthcare regulators issued renewed warnings to patients using Medtronic’s (NYSE:MDT) Paradigm insulin pumps, cautioning that an accidental button-press may result in a potentially dangerous overdose.
Changes to Australia’s radiofrequency spectrum could affect medical devices
Australia’s Therapeutic Goods Administration is advising that upcoming changes to to radiofrequency spectra Down Under could affect "a small number" of medical devices.
The TGA said the changes, planned for next month, are being made by the Australian Communication & Media Authority to facilitate the changeover from analog to digital devices.
Labeling glitch with Boston Scientific’s Promus Element Plus prompts recall in Australia
Boston Scientific (NYSE:BSX) shipped some of its Promus Element Plus Monorail coronary stents with the wrong labels in Australia, prompting that country’s Therapeutic Goods Administration to issue a recall.
Australian regulators launch adverse event database
By Stewart Eisenhart, Emergo Group
The Therapeutic Goods Administration (TGA), Australia’s medical device market regulator, has launched a new searchable database of adverse event information, the Database of Adverse Event Notifications (DAEN), available to the public.
Australian regulators propose changes to IVD oversight plan
By Stewart Eisenhart, Emergo Group
Australia’s Therapeutic Goods Administration (TGA) has published proposed changes to upcoming in vitro diagnostic (IVD) regulations for comment ahead of a proposed final implementation date of July 2014.
High-level components of the new Australian IVD regulatory scheme include:
