Blogs

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 EU Compliance and Enforcement Group (COEN) recently released a new guidance document that provides information to the industry on how to design their instructions for use for re-usable and re-sterilizable devices. This new guidance document explains the EC’s view...

I think I can speak for most people when I say that viable treatments and vaccines are desperately needed at this point to overcome the COVID-19 global pandemic. Not only that COVID-19 has taken so many lives across the globe,...

In recent years, the field of regenerative medicine has gained significant traction and been pointed to as the future wave of medicine. Regenerative medicine focuses on replacing tissues or organs that have been damaged by disease or other conditions and...

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...

Back in May, the FDA announced its intention to re-start domestic routine inspections (which you can read more about in our blog here). Last week, the FDA announced that it is planning to restart some on-site surveillance activities the week...