Last week, the FDA finalized guidance for medical device establishment inspections, which satisfies a requirement of the FDA Reauthorization Act (FDARA) of 2017. The FDARA was signed into law on August 18, 2017, and amends the Federal Food, Drug, and...
The COVID-19 pandemic has forced some of the most drastic loosening of regulatory requirements the FDA has ever done. Relaxed regulations allow quick access to critical medical devices necessary to fight the pandemic, but what will happen to the medical...
When COVID-19 caused the Commission to delay the MDR date of application by a year (May 2021), it was advised that the extra year be spent ensuring compliance with the new regulation. As the pandemic continues to pose an obstacle...
The FDA has recently released a new emergency use authorization (EUA) template aimed at developers of at-home sample collection kits for COVID-19 tests. EUA’s are the FDA’s provision which allows the use of unapproved medical products when there are no...
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...
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...
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...
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...