Last week the FDA released a new compliance program for inspections of CDER-led or CDRH-led combination products to streamline the approach regarding cGMP’s and inspections. This new program was released as part of an update to the Compliance Program Guidance...
In light of the COVID-19 pandemic, the EU commission adopted the Regulation (EU) 2020/561 that deferred the application of the EU Medical Device Regulations, which were set to go into effect in May 2020 by a year. This also means...
As medical device firms adjust to the new normal in light of COVID-19 hurdles, the FDA continues to issue guidances and relax regulatory requirements to accommodate. Disruptions to global supplies and the challenge of social distance restrictions may be the...
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...