Manufacturers Mentor and Sientra did not adequately comply with post-approval study requirements that look at the long-term safety and risks of silicone implants.
The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.
The document aims to clear up how the agency looks at device functions that aren’t subject to premarket review of safety and effectiveness.
When device modifications could affect safety and effectiveness, a premarket notification submission is required.
It’s more than a bolt-on. Here’s a smart approach to integrate medical devices into connected systems.
The agency is creating a virtual center of excellence to expedite the development of combination products.
There are several steps you can take to ensure your mHealth app is keeping patient health data safe and secure.
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 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.
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.