Requirements

In an effort to accelerate the production of tests for COVID-19, FDA released a new guidance document that will allow for clinical laboratories and commercial manufacturers to accelerate the development of COVID-19 tests. In this guidance document, FDA outlines its...

Back in March amid the beginning of the COVID-19 pandemic, the FDA announced that in addition to postponing all international inspections, it would also be temporarily halting all domestic routine surveillance inspections. This unusual move by the agency was made...

The effects of COVID-19 have been widespread across different parts of the medical device world, but the Digital Health sector has seen the most growth because of the pandemic. The scope of digital health includes mobile health, health information technology,...

COVID-19 has severely disrupted the medical device supply chain. Device manufacturers are typically not required to report shortages of device supplies or interruptions in the production to the FDA. However, in light of the pandemic situation, CDRH requires that device...

The COVID-19 pandemic has had a broad and prevalent impact on the FDA and “normal” medical device life as the industry knows it. Everything from routine inspections to premarket notification reviews have been disrupted by the pandemic, and clinical trials...

In Europe, medical devices are regulated under the Directive 93/42/EEC—the “Medical Devices Directive” (MDD) which is annulled by the Medical Devices Regulation (MDR) (EU) No. 2017/745, whereas Personal Protective Equipment is regulated under Regulation (EU) 2016/425 (the PPE regulation), which...

Just like every other nation, Australia has also taken several measures to respond to the global pandemic. To help prevent shortages of medical equipment and personal protective equipment, the Australian regulating authority- Therapeutic Goods Administration (TGA) has announced several exemptions...

In our last blog on COVID-19’s impact on the EU MDR, the commission had not yet laid out any intentions of moving the EU MDR deadline, which was slated for next month. With close to 2 million confirmed cases globally,...

Canada has been facing the same difficulties as many other nations due to the novel coronavirus. In light of the shortage of medical equipment and the PPEs, Health Canada relaxed their policies to let medical equipment and other necessary supplies...