In the current scenario of COVID-19, protective gown is considered as one of the critical products for immediate supply. But with the decline in the global supply chains of protective gowns, meeting the demand right on time would be challenging.
To ensure the world sustain the ever-growing demand in this time of emergency, as a prominent protective gown manufacturer, you might be willing to market your product across the globe or to be specific in the USA. But do you know how Gown (Protective) is classified in the USA by the United States Food and Drug Administration (US FDA)? How US FDA regulates protective gowns?
Have all your questions answered regarding:
- Protective Gown Registration/notification in the USA
- US FDA Protective Gown Regulations
In addition, some global health authorities have already expedited their Regulatory pathways for protective gowns. The dynamic nature of those developments might require manufacturers to be more attentive on the regional Regulatory aspects, too. In such a case, streamline protective gowns’ global market entry with the best of regional Regulatory information and structural Regulatory approach.
As a responsible Regulatory partner, Freyr has already started assisting clients to accelerate and fast track registrations/notifications of protective gown in the USA.