Special controls are also provided for reasonable assurance of the safety and effectiveness of the devices impacted by the reclassification.
The agency recently released a guidance document that gives device manufacturers an optional pathway to make certain modifications to their device.
CooperVision, Inc. and Pentax of America won the agency approvals, respectively.
There are several critical questions that your internal team should be ready to address when preparing product portfolios and seeking out a CRO.
This new pathway is a considerable change for the medical device industry.
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.