Regulatory

Medical Device user fees are something all medical device firms should be well acquainted with. Under the user fee system, medical device companies must pay fees to the FDA when they register their establishments and list their devices. Additionally, there...

As technology advances, more and more medical devices are being engineered with multiple functions. According to the FDA, any product that has at least one medical device function and one non-device function is considered a “multiple function device product”. At...

Currently, we live in a world driven by the 4th Industrial Revolution in which science and technology are continuously evolving. But what exactly is Industry 4.0? It is the process of using tech platforms like Cloud, IoT, AI, and Analytics...

The US Food and Drug Administration released a final rule to exempt additional product codes from the requirements of 510(k) submission. FDA believes that this exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs...

The International Medical Device Regulators Forum (IMDRF) has recently issued a final guidance document to outline its expectations around the regulatory landscape for personalized medical devices. This recent guidance document builds on the previous IMDRF document, ‘Definitions for Personalized Medical...

May 2020 deadline for the EU MDR is fast approaching and the industry is scrambling to find the right resources and understand the application of the regulation to their products. Unlike the FDA, the EU does not have clear directions on...

How does gene therapy fit into the FDA? Is it a medical device, a drug, or a combination product? What if gene therapy can cure a life-threatening disease? There are a lot of questions that can pop into your mind...

Are you looking to expand your consumer base and grow your business? International marketing is beneficial by creating long-term business relationships and increasing brand reputation. Expanding your market to a country like Australia is a smart commercial move, but how...

Whenever there is a public health emergency, such as the Zika virus in 2016 or the current novel coronavirus, there is a rush to get diagnostic tests and other medical products to detect and treat the emergency available quickly. Given...