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 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.
Device companies need to think about how their product interacts with systems and users.