Coronavirus

Internal audits are a critical activity for every medical device firm. Not only are they mandatory per 21 CFR 820.22 and Clause 8.2.4 of ISO 13485:2016, but they are also fundamental in ensuring continuous review and improvement of a quality...

Hand sanitizers in Canada are regulated by the Natural and Non-Prescription Health Products Directorate (NNHPD). When the pandemic was at its peak, NNHPD released an interim guidance for expedited approval of hand sanitizers to help mitigate supply shortages. The expedited...

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...

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...