Regulatory

Built and powered by data-intensive platforms such as Human-Computer Interaction (HCI), AI, Cloud Computing, Big Data, and the Internet of Things (IoT), wearable technologies are gaining more significance and popularity. The best example of a wearable smart device is a...

Homeopathic medicines have been around since the 1700s, and the premise behind them has not changed much in the past 300 years. The idea behind them is the premise of “like cures like”, meaning that the substance that causes a...

The EUDAMED Actors module is all set to start accepting registrations from member states and economic operators from 1st December 2020.  EUDAMED is a portal that consists of 6 modules and the Actors module serves as the establishment registration portal...

Continuously growing elements of the Industry 4.0 are the bits and bytes, or data. With platforms like Internet of Things and Cloud, on average, an individual is producing 1.70 megabytes of data every second.1 With such massive dataflows which also...

It is no secret that brand-name drugs in America are often expensive. Luckily, for the many American’s who are not able to afford those brand-name drugs, generic drugs are an option. Most people are somewhat familiar with the concept of...

Now more than ever, the Emergency Use Authorization (EUA) pathway for medical devices has become a popular topic. Due to the COVID-19 pandemic, there is an unprecedented number of EUA devices on the market, with many products being manufactured by...

The US FDA’s Center for Devices and Radiological Health (CDRH) announced a new pilot program that will allow the industry to submit premarket submissions electronically during the COVID-19 health emergency.1 The Electronic Delivery of Premarket Submissions Pilot Program’s objective is to...

One of the paradigms of the next generation computing tools is Augmented Reality (AR) where animated objects are superimposed on real-world objects. A live video or an image is initially scanned, detected, analyzed, and the required animated objects are added...

Few people outside of the industry know how big of a role the FDA has in product labeling and packaging. Every product approved by the FDA has very specific guidelines for its packaging and labeling, and these guidelines are often...

The De Novo pathway establishes new classification categories for novel low-to-moderate risk devices, which in turn allows similar devices to leverage the De Novo device as a predicate. In recent years, the De Novo pathway has proven to become much...