In the current scenario of COVID-19, Pulse Oximeter (Fingertip) is considered as one of the critical products for immediate supply. But with the decline in the global supply chains of fingertip pulse oximeter, 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 pulse oximeter (fingertip) manufacturer, you might be willing to market your product across the globe or to be specific in the USA. But do you know how fingertip pulse oximeter is classified in the USA? How United States Food and Drug Administration (US FDA) regulates fingertip pulse oximeter?
Have all your questions answered regarding:
- Pulse Oximeter (Fingertip) Registration/notification in the USA
- US FDA Pulse Oximeter (Fingertip) Regulations
In addition, some global health authorities have already expedited their Regulatory pathways for fingertip pulse oximeter. The dynamic nature of those developments might require manufacturers to be more attentive on the regional Regulatory aspects, too. In such a case, streamline fingertip pulse oximeter 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 pulse oximeter (fingertip) in the USA.