This short, 6-page guidance casts a long shadow across the medical device landscape. The guidance states that the agency will reject an application that fails to provide adequate cybersecurity measures in premarket applications — just one of several recent developments that show just how serious the U.S. federal government is about cybersecurity.
Several features of this draft suggest companies will have to do a significant amount of work in the premarket phase for development of a predetermined change control protocol (PCCP), making the development process potentially lengthier and more expensive.
The FDA has released a framework for the use of digital health technologies (DHTs) in the development of pharmaceuticals and biologics, but the FDA’s Center for Devices and Radiological Health (CDRH) will be intimately involved in this project.
There is a growing — and disconcerting — trend in which FDA resorts to regulation and lawmaking by fiat, overstepping the authority granted to it by Congress. Of particular concern are recent actions taken in regard to clinical decision support (CDS) software and laboratory-developed tests (LDTs).
The FDA has released a discussion paper on the use of artificial intelligence (AI) in the drug manufacturing process, raising a host of questions about issues such as the use of cloud services for manufacturing data management. Perhaps the key consideration posed by the paper is whether AI will enable the broad adoption of advanced drug manufacturing, which the FDA has been trying to encourage for nearly 20 years.
The CDS Coalition has filed a citizen petition to have the FDA withdraw its final guidance for clinical decision support (CDS) software, a development that could prove essential to unlocking the market for these products.
The FDA has released a draft guidance for an alternative to its traditional medical device reporting (MDR) program — the voluntary malfunction summary reporting (VMSR) program — which eases the burden of post-market surveillance for a large number of device types.
A new guidance from the Medical Device Coordination Group (MDCG) clarifies that software as a medical device (SaMD) product can operate under a limited amount of regulatory oversight when deployed only in a single healthcare entity, which gives smaller developers an opportunity to gain a foothold in the European Union (EU) while they add to their to-market capabilities.
Augmented reality and virtual reality (AR/VR) might never dominate the world of medical technology the way cardiology devices once had, but AR/VR products are becoming more important as digital health and telehealth play an increasingly central role in 21st Century healthcare.
The field of augmented reality/virtual reality (AR/VR) is the subject of nearly 40 FDA marketing authorizations in the past few years, but this is still a relatively unexplored technological area. The FDA’s medical extended reality (MXR) program was established in 2021 to address some of the deficits in methods for validating AR/VR products.
Electronic Quality Management System
Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise
