MobiHealthNews

Medco medication adherence app registered with FDA as Class 1 device

This morning at the FDA's public Workshop on its Mobile Medical Applications Draft Guidance, which it published in July, FDA senior advisor Bakul Patel noted that Medco had registered its smartphone ...
JD Supra

Changes of the Amended Regulations on Supervision and Administration of Medical Devices

The requirements for Class 1 medical devices (medical devices with low risks and their safety and effectiveness can be ensured through routine administration) have been reduced to filing as opposed to ...
Purdue University

Novel device that enables blood collection anytime and anywhere listed with the FDA

WEST LAFAYETTE, Ind. – A device that makes it faster and more convenient to collect and process blood samples has been registered by the U.S. Food and Drug Administration (FDA) as a Class 1 Medical ...
MobiHealthNews

FDA finalizes plans to deregulate MDDS health software

Last June in a draft guidance document, the FDA proposed to further de-regulate a specific type of health software, which included a number of mobile medical apps and telehealth platforms, from ...
MD&M East

Medical Device Marking and Labeling

Medical device labeling is considered as important as classifying a product or creating an insulation diagram. In IEC 60601-1, labeling is deemed "a critical component of a medical device." 1 The ...