FDA Releases Draft Guidance for Multiple Function Devices
The document aims to clear up how the agency looks at device functions that aren’t subject to premarket review of safety and effectiveness.
Tag Archives: safety
Made a Design Change? Inform FDA
When device modifications could affect safety and effectiveness, a premarket notification submission is required.
Adding Connectivity to Your Medical Device
It’s more than a bolt-on. Here’s a smart approach to integrate medical devices into connected systems.
Combination Products to Get Part of $5.1 Billion Requested FDA Budget
The agency is creating a virtual center of excellence to expedite the development of combination products.
Mobile Apps in the Medical Device Industry: Safety, Security and Patient Privacy
There are several steps you can take to ensure your mHealth app is keeping patient health data safe and secure.
Biological Evaluation of Medical Devices
The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.
The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.
UDI: What You Need to Know About Timelines, Compliance and Submissions
The legislated FDA Unique Device Identification regulation is a single device identification system that is invariable, absolute, standardized, and globally reconciled. All medical device manufacturers will be required to comply with the new UDI approach. Here’s some information for you to get started.
The legislated FDA Unique Device Identification regulation is a single device identification system that is invariable, absolute, standardized, and globally reconciled. All medical device manufacturers will be required to comply with the new UDI approach. Here’s some information for you to get started.
Meeting Your Electrical Safety and Quality Requirements
Compliance with 60601-1 is not just about electrical safety; it is also about addressing mechanical, structural and environmental factors, and following a process to address usability, risk management and software development.
Compliance with 60601-1 is not just about electrical safety; it is also about addressing mechanical, structural and environmental factors, and following a process to address usability, risk management and software development.
