FDA Approves First Contraceptive Mobile App

USA – FDA Approves First Contraceptive Mobile App

A Swedish startup company obtained US Food and Drug Administration (FDA) approval Friday for the country’s first mobile medical app indicated for contraceptive use. The...
US FDA Updates UDI Policy for Direct Marking of Medical Devices

USA – US FDA Updates UDI Policy for Direct Marking of Medical Devices

EMERGO SUMMARY OF KEY POINTS: US FDA has revised UDI direct marking requirements and deadlines for some non-sterile, Class I and unclassified medical devices. ...
GS1 Guidance to Support Point-of-Care Scanning of UDI Data for Implantable Devices

USA – GS1 Guidance to Support Point-of-Care Scanning of UDI Data for Implantable Devices

Standards development organization GS1 US unveiled an implementation guidance aimed at providing support for health care providers in capturing unique device identifiers (UDIs) for...

USA – What Went Wrong With COVID-19 Testing? FDA Points to Slow Deployment of...

As hospitals as well as state and commercial labs have now ramped up their testing for the novel coronavirus to almost 100,000 tests per...
Gottlieb Defends Digital Health Approach

USA – Gottlieb Defends Digital Health Approach

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday defended the agency’s approach to regulating digital health apps following the de novo...
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Canada – Health Canada Proposes Changes to Priority Review Requests for Medical Devices

Health Canada intends to modify its policy for medical device manufacturers to request priority reviews by nixing its requirement on a separate submission and...
Coronavirus delays many FDA foreign inspections

USA – FDA Removes 9% of Medical Device Registrations from Database

In March 2019, the U.S. Food and Drug Administration (FDA) removed approximately 2,551 medical device establishment registrations from its database, a decrease of...
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Canada – Regulatory considerations on the classification of non-medical masks or face coverings

About non-medical masks or face coverings Non-medical masks or face coverings may help reduce the spread of respiratory droplets from the user to others or...
First Version of NEST to Launch in 2019

USA – First Version of NEST to Launch in 2019

The National Evaluation System for health Technology (NEST) will become increasingly crucial for tracking medical devices at FDA’s Center for Devices and Radiological Health...
Considering Old and New 510(k) Predicates

USA – Considering Old and New 510(k) Predicates

The 510(k) route to market for Class II devices involves the comparison of the candidate device to a legally marketable (already cleared) device. Note...

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