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,...
Back in Mid-March, when the COVID-19 pandemic was starting to take off in the US, the FDA issued a policy that allowed antibody tests to enter the market without securing an EUA. This was intended to provide hospitals and labs...
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...
The COVID-19 pandemic has caused mass shortages of ventilators and PPE globally, but now healthcare workers are starting to see the effects of the pandemic on supplies of infusion pumps. Hospitals are starting to see their supply of infusion pumps,...
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,...