COVID-19 EUA and Enforcement Policy Transition Plans
In December of 2021, the FDA issued two draft guidance documents for transition plans for medical devices that were issued Emergency Use Authorizations (EUAs) and for…
FDA ISO Harmonization: What Does It Mean, and What Should We Do Next?
The FDA has announced that their current quality system regulation will be replaced by one incorporating references to ISO 13485:2016. This is a major change in…